Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 13, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 0-25466 | |
Entity Registrant Name | CYCLO THERAPEUTICS, INC | |
Entity Incorporation, State or Country Code | NV | |
Entity Tax Identification Number | 59-3029743 | |
Entity Address, Address Line One | 6714 NW 16th Street, Suite B | |
Entity Address, City or Town | Gainesville | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 32653 | |
City Area Code | 386 | |
Local Phone Number | 418-8060 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 22,732,402 | |
Entity Central Index Key | 0000922247 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Common Stock [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common Stock, par value $.0001 per share | |
Trading Symbol | CYTH | |
Security Exchange Name | NASDAQ | |
Warrants To Purchase Common Stock [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Warrants to purchase Common Stock | |
Trading Symbol | CYTHW | |
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets (Cu
Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 1,801,809 | $ 1,543,418 |
Accounts receivable, net | 303,760 | 54,991 |
Inventory, net | 209,755 | 254,491 |
Prepaid insurance and services | 150,322 | 101,135 |
Prepaid clinical expenses | 3,045,870 | 2,204,520 |
Total current assets | 5,511,516 | 4,158,555 |
FURNITURE AND EQUIPMENT, NET | 40,731 | 55,188 |
RIGHT-OF-USE LEASE ASSET, NET | 44,819 | 1,470 |
TOTAL ASSETS | 5,597,066 | 4,215,213 |
Current portion of lease liability | 17,973 | 0 |
Accounts payable and accrued expenses | 6,604,504 | 3,480,669 |
Total current liabilities | 6,622,477 | 3,480,669 |
LONG-TERM LIABILITIES | ||
Lease liability, net of current portion | 27,259 | 0 |
Total long-term liabilities | 27,259 | 0 |
STOCKHOLDERS' EQUITY (DEFICIT) | ||
Common stock, par value $.0001 per share, 50,000,000 and 20,000,000 shares authorized, 19,365,089 and 8,481,848 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 1,937 | 849 |
Preferred stock, par value $.0001 per share, 5,000,000 shares authorized, 0 outstanding | 0 | 0 |
Additional paid-in capital | 77,159,665 | 64,533,074 |
Accumulated deficit | (78,214,272) | (63,799,379) |
Total stockholders' equity (deficit) | (1,052,670) | 734,544 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | $ 5,597,066 | $ 4,215,213 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized (in shares) | 50,000,000 | 20,000,000 |
Common Stock, Shares, Issued (in shares) | 19,365,089 | 8,481,848 |
Common Stock, Shares, Outstanding (in shares) | 19,365,089 | 8,481,848 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued (in shares) | 0 | 0 |
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
REVENUES | ||||
Product sales | $ 495,477 | $ 452,167 | $ 765,006 | $ 1,188,957 |
EXPENSES | ||||
Personnel | 834,878 | 887,506 | 2,526,700 | 3,075,170 |
Cost of products sold (exclusive of direct and indirect overhead and handling costs) | 38,767 | 33,032 | 68,872 | 123,163 |
Research and development | 3,469,067 | 2,856,160 | 10,037,433 | 5,814,595 |
Repairs and maintenance | 847 | 2,177 | 9,162 | 10,175 |
Professional fees | 597,095 | 611,685 | 1,494,332 | 1,673,582 |
Office and other | 220,607 | 204,654 | 775,922 | 790,441 |
Board of Directors fees and costs | 95,560 | 98,126 | 243,143 | 314,382 |
Depreciation | 4,819 | 5,129 | 14,457 | 14,611 |
Freight and shipping | 1,297 | 2,198 | 2,519 | 11,819 |
Total operating expenses | 5,262,937 | 4,700,667 | 15,172,540 | 11,827,938 |
LOSS FROM OPERATIONS | (4,767,460) | (4,248,500) | (14,407,534) | (10,638,981) |
OTHER INCOME (EXPENSE) | ||||
Investment and other income | (3,893) | 1,620 | (7,359) | 9,996 |
Gain on forgiveness of PPP loan | 0 | 158,524 | ||
Total other income (expense), net | (3,893) | 1,620 | (7,359) | 168,520 |
LOSS BEFORE INCOME TAXES | (4,771,353) | (4,246,880) | (14,414,893) | (10,470,461) |
PROVISION FOR INCOME TAXES | 0 | 0 | 0 | 0 |
NET LOSS | $ (4,771,353) | $ (4,246,880) | $ (14,414,893) | $ (10,470,461) |
BASIC AND DILUTED NET LOSS PER COMMON SHARE (in dollars per share) | $ (0.29) | $ (50) | $ (1) | $ (1.24) |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING (in shares) | 16,191,723 | 8,447,630 | 14,394,920 | 8,428,074 |
Paycheck Protection Program CARES Act [Member] | ||||
OTHER INCOME (EXPENSE) | ||||
Gain on forgiveness of PPP loan | $ 0 | $ 0 | $ 0 | $ 158,524 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] Share-Based Payment Arrangement, Nonemployee [Member] | Common Stock [Member] Share-Based Payment Arrangement, Employee [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] Share-Based Payment Arrangement, Nonemployee [Member] | Additional Paid-in Capital [Member] Share-Based Payment Arrangement, Employee [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] Share-Based Payment Arrangement, Nonemployee [Member] | Retained Earnings [Member] Share-Based Payment Arrangement, Employee [Member] | Retained Earnings [Member] | Share-Based Payment Arrangement, Nonemployee [Member] | Share-Based Payment Arrangement, Employee [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 8,403,869 | |||||||||||
Balance at Dec. 31, 2021 | $ 841 | $ 64,019,513 | $ (48,348,491) | $ 15,671,863 | ||||||||
Stock issued to nonemployees (in shares) | 44,083 | |||||||||||
Stock issued to nonemployees | $ 4 | $ 113,008 | $ 0 | $ 113,012 | ||||||||
Stock-based compensation | 0 | 282,296 | 0 | 282,296 | ||||||||
Net loss | $ 0 | 0 | (10,470,461) | (10,470,461) | ||||||||
Stock issued to employees (in shares) | 7,500 | |||||||||||
Stock issued to employees | $ 1 | $ 15,749 | $ 0 | $ 15,750 | ||||||||
Balance (in shares) at Sep. 30, 2022 | 8,455,452 | |||||||||||
Balance at Sep. 30, 2022 | $ 846 | 64,430,566 | (58,818,952) | 5,612,460 | ||||||||
Balance (in shares) at Jun. 30, 2022 | 8,439,435 | |||||||||||
Balance at Jun. 30, 2022 | $ 844 | 64,311,270 | (54,572,072) | 9,740,042 | ||||||||
Stock-based compensation | 0 | 88,546 | 0 | 88,546 | ||||||||
Net loss | $ 0 | 0 | (4,246,880) | (4,246,880) | ||||||||
Stock issued to employees (in shares) | 16,017 | |||||||||||
Stock issued to employees | $ 2 | $ 30,750 | $ 0 | $ 30,752 | ||||||||
Balance (in shares) at Sep. 30, 2022 | 8,455,452 | |||||||||||
Balance at Sep. 30, 2022 | $ 846 | 64,430,566 | (58,818,952) | 5,612,460 | ||||||||
Balance (in shares) at Dec. 31, 2022 | 8,481,848 | |||||||||||
Balance at Dec. 31, 2022 | $ 849 | 64,533,074 | (63,799,379) | 734,544 | ||||||||
Exercise of stock options (in shares) | 1,155 | |||||||||||
Exercise of stock options | $ 0 | 1,478 | 1,478 | |||||||||
Stock issued to nonemployees (in shares) | 195,537 | |||||||||||
Stock issued to nonemployees | $ 20 | 219,694 | $ 0 | 219,714 | ||||||||
Stock-based compensation | 0 | 259,430 | 0 | 259,430 | ||||||||
Net loss | $ 0 | 0 | (14,414,893) | (14,414,893) | ||||||||
Sale of common stock and accompanying warrants, net (in shares) | 9,007,853 | |||||||||||
Sale of common stock and accompanying warrants, net | $ 900 | 12,145,989 | 0 | 12,146,889 | ||||||||
Exercise of warrants, net (in shares) | 1,678,696 | |||||||||||
Exercise of warrants, net | $ 168 | 0 | 0 | 168 | ||||||||
Balance (in shares) at Sep. 30, 2023 | 19,365,089 | |||||||||||
Balance at Sep. 30, 2023 | $ 1,937 | 77,159,665 | (78,214,272) | (1,052,670) | ||||||||
Balance (in shares) at Jun. 30, 2023 | 15,308,449 | |||||||||||
Balance at Jun. 30, 2023 | $ 1,531 | 71,956,553 | (73,442,919) | (1,484,835) | ||||||||
Sale of common stock (in shares) | 4,000,000 | |||||||||||
Sale of common stock | $ 400 | 4,999,600 | 0 | 5,000,000 | ||||||||
Exercise of stock options (in shares) | 1,155 | |||||||||||
Exercise of stock options | $ 0 | 1,478 | 0 | 1,478 | ||||||||
Stock issued to nonemployees (in shares) | 55,485 | |||||||||||
Stock issued to nonemployees | $ 6 | $ 75,454 | $ 75,460 | |||||||||
Stock-based compensation | 0 | 126,580 | 0 | 126,580 | ||||||||
Net loss | $ 0 | 0 | (4,771,353) | (4,771,353) | ||||||||
Balance (in shares) at Sep. 30, 2023 | 19,365,089 | |||||||||||
Balance at Sep. 30, 2023 | $ 1,937 | $ 77,159,665 | $ (78,214,272) | $ (1,052,670) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (14,414,893) | $ (10,470,461) |
Accounts receivable, net | (248,769) | 120,298 |
Inventory, net | 44,736 | (43,700) |
Prepaid clinical expenses | (841,350) | (1,335,151) |
Prepaid insurance and services | (49,187) | (73,643) |
Other | 1,883 | 0 |
Accounts payable and accrued expenses | 3,123,835 | (810,194) |
Total adjustments | 2,524,749 | (1,897,000) |
NET CASH USED IN OPERATING ACTIVITIES | (11,890,144) | (12,367,461) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 14,457 | 14,611 |
Gain on forgiveness of PPP loan | 0 | (158,524) |
Provision for doubtful accounts | 0 | (21,755) |
Stock-based compensation | 259,430 | 282,296 |
Stock compensation to employees | 0 | 15,750 |
Stock compensation to nonemployees | 219,714 | 113,012 |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of equipment | 0 | (15,086) |
Collections from mortgage note receivable | 0 | 53,256 |
NET CASH PROVIDED BY INVESTING ACTIVITIES | 0 | 38,170 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Net proceeds from sale of warrants | 2,917,581 | 0 |
Net proceeds from sale of stock | 9,229,308 | 0 |
Exercise of stock options | 1,478 | 0 |
Exercise of warrants | 168 | 0 |
NET CASH PROVIDED BY FINANCING ACTIVITIES | 12,148,535 | 6,778 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | 258,391 | (12,322,513) |
CASH AND CASH EQUIVALENTS, beginning of period | 1,543,418 | 16,612,711 |
CASH AND CASH EQUIVALENTS, end of period | 1,801,809 | 4,290,198 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||
Cash paid for interest | 9,807 | 0 |
Paycheck Protection Program CARES Act [Member] | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Gain on forgiveness of PPP loan | 0 | (158,524) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Payments on PPP loan | 0 | (8,159) |
Refund of PPP loan payments | $ 0 | $ 14,937 |
Note 1 - Organization and Descr
Note 1 - Organization and Description of Business | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Organization and Description of Business [Text Block] | (1) ORGANIZATION AND DESCRIPTION OF BUSINESS: Cyclo Therapeutics, Inc. (the “Company,” “we,” “our” or “us”) was 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 neurodegenerative diseases. 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 autosomal recessive genetic disease resulting in disrupted cholesterol metabolism that impacts the brain, lungs, liver, spleen, and other organs. In 2015, we launched an International Clinical Program for Trappsol® Cyclo™ as a treatment for NPC. In 2016, we filed an Investigational New Drug application (“IND”) with the FDA, which described our Phase I clinical plans for a randomized, double blind, parallel group study at a single clinical site in the U.S. The Phase I study evaluated the safety and pharmacokinetics of Trappsol® Cyclo™ along with markers of cholesterol metabolism and markers of NPC during a 12-week treatment period of intravenous administration of Trappsol® Cyclo™ every two weeks to participants 18 years of age and older. The IND was approved by the FDA in September 2016, and in January 2017 the FDA granted Fast Track designation to Trappsol® Cyclo™ for the treatment of NPC. Initial patient enrollment in the U.S. Phase I study commenced in September 2017, 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 completed a Phase I/II clinical study approved by European regulatory bodies with clinical trial centers in the United Kingdom, Sweden, and in Israel. The Phase I/II study evaluated the safety, tolerability and efficacy of Trappsol® Cyclo™ through a range of clinical outcomes, including neurologic, respiratory, and measurements of cholesterol metabolism and markers of NPC. Consistent with the 12-week phase 1 study (single US site), the European/Israel study administered Trappsol® Cyclo™ intravenously to NPC patients every two weeks in a double-blind, randomized trial, but differs in that the study period was for 48 weeks (24 doses). In March of 2021 we announced that 100% of patients who completed the trial (9 out of 12) improved or remained stable, and 89% met the efficacy outcome measure of improvement in at least two domains of the 17-domain NPC severity scale. 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, and in June of 2021 we commenced enrollment in TransportNPC, a pivotal Phase III study of Trappsol® Cyclo™ for the treatment of NPC. 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. 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 incorporated the feedback into an IND for a Phase II study for the treatment of Alzheimer’s disease with Trappsol® Cyclo™ that we submitted to the FDA in November 2021. In December of 2021, we received IND clearance from the FDA, allowing us to proceed with our Phase II study of Trappsol® Cyclo™ for the treatment of Alzheimer’s disease. U.S. sites for the study were activated during the second half of 2022, and patient dosing began in the first quarter of 2023. (1) ORGANIZATION AND DESCRIPTION OF BUSINESS: ( We also continue to operate our legacy fine chemical business, consisting of the sale of cyclodextrins and related products to the pharmaceutical, nutritional, and other industries, primarily for use in diagnostics and specialty drugs. However, our core business has transitioned to a biotechnology company primarily focused on the development of cyclodextrin- based biopharmaceuticals for the treatment of disease from a business that had been primarily reselling basic cyclodextrin products. Merger Agreement On September 21, 2023, the Company and its wholly-owned subsidiary (“Merger Sub”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Applied Molecular Transport Inc., a Delaware corporation (“AMTI”). Pursuant to the terms of the Merger Agreement, the Merger Sub will be merged with and into AMTI (the “Merger”), with AMTI surviving the Merger as a wholly-owned subsidiary of the Company. At the closing of the Merger, each outstanding share of AMTI common stock will be converted into the right to receive a number of shares of the Company’s common stock calculated in accordance with the Merger Agreement (the “Exchange Ratio”). In addition, the Company will assume all outstanding AMTI stock options, which have an exercise price equal to $0.40 [1] [2] Upon the closing of the Merger, the Company expects to issue approximately 7.6 million shares of the Company’s common stock to AMTI stockholders, which is approximately 25% of the combined company after the Merger. The number of shares to be issued in the Merger and the Exchange Ratio will be subject to adjustment based on the amount of AMTI’s net cash at the closing and the number of shares of AMTI common stock outstanding at the closing of the Merger. In connection with the Merger, the Company will seek the approval of its stockholders to (a) issue the shares of the Company’s common stock issuable in connection with the Merger (“Share Issuance Proposal”) under the rules of The Nasdaq Stock Market LLC (“Nasdaq”). Consummation of the Merger is subject to certain closing conditions, including, among other things, (1) approval by the Company’s stockholders of the Share Issuance Proposal, (2) approval by the AMTI stockholders of the adoption of the Merger Agreement, (3) the effectiveness of the registration statement on Form S-4 filed in connection with the Merger, and (4) Nasdaq’s approval of the listing of the shares of the Company’s common stock to be issued in connection with the Merger. Each party’s obligation to consummate the Merger is also subject to other specified customary conditions, including the representations and warranties of the other party being true and correct as of the date of the Merger Agreement and as of the closing date of the Merger, generally subject to an overall material adverse effect qualification, and the performance in all material respects by the other party of its obligations under the Merger Agreement required to be performed on or prior to the date of the closing of the Merger. The Merger Agreement contains specified termination rights of each of the Company and AMTI. If the Merger Agreement is terminated by either the Company or AMTI due to the Company’s failure to receive the requisite approval of its stockholders, the Company will be required to reimburse AMTI for up to $450,000 of expenses incurred in connection with the transaction. |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: The following is a summary of the more significant accounting policies of the Company that affect the accompanying condensed consolidated financial statements: (a) BASIS OF PRESENTATION––The condensed consolidated financial statements include the Company and its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. The interim condensed consolidated financial statements of the Company included in this Quarterly Report on Form 10-Q, including these notes, are unaudited. In the opinion of management, all adjustments necessary for a fair presentation of the condensed consolidated financial statements have been included. Such adjustments are of a normal, recurring nature. The condensed consolidated financial statements, and these notes, have been prepared in accordance with Generally Accepted Accounting Principles and do not contain certain information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022. The condensed consolidated financial statements should be read in conjunction with that Annual Report on Form 10-K. Results for the interim periods presented are not necessarily indicative of the results that might be expected for the entire fiscal year. (b) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original purchased maturity of three months or less. (c) ACCOUNTS RECEIVABLE––Accounts receivable are unsecured and non-interest bearing and stated at the amount we expect to collect from outstanding balances. Customer account balances with invoices dated over 90 days old are considered past due. The Company does not accrue interest on past due accounts. Customer payments are allocated to the specific invoices identified on the customer’s remittance advice or, if unspecified, applied to the oldest unpaid invoices. The carrying amount of accounts receivable is reduced by an allowance for credit losses that reflects management’s best estimate of expected credit losses. The Company reviews each customer balance where all or a portion of the balance exceeds 90 days from the invoice date. Based on the Company’s assessment of the customer's current and forecasted 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. The Company has estimated an allowance for doubtful accounts of approximately $10,300 at September 30, 2023 and December 31, 2022. (d) INVENTORY AND COST OF PRODUCTS SOLD––Inventory consists of our pharmaceutical drug Trappsol® Cyclo™, cyclodextrin products and chemical complexes purchased for resale recorded at the lower of cost (first-in, first-out) or net realizable value. Cost of products sold includes the acquisition cost of the products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense. The Company records a specific reserve for inventory items that are determined to be obsolete. The reserve for obsolete inventory was approximately $52,900 at September 30, 2023 and December 31, 2022. 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. (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: (e) 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. In addition, advance payments for goods or services for future research and development activities are included as prepaid clinical expenses. Prepaid clinical expenses are expensed as research and development costs as the goods are delivered or the related services are performed. (f) FURNITURE AND EQUIPMENT––Furniture and equipment are recorded at cost, less accumulated depreciation. Depreciation is computed using primarily the straight-line method over the estimated useful lives of the assets (generally three five seven ten (g) LEASES––The Company leases office and warehouse space. The Company determines if an arrangement is a lease at inception. Operating leases are included in lease right-of-use (ROU) assets and lease liabilities on the Company’s condensed consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The lease ROU asset also includes any lease payments made and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. In evaluating contracts to determine if they qualify as a lease, the Company considers factors such as if the Company has obtained substantially all of the rights to the underlying asset through exclusivity, if it can direct the use of the asset by making decisions about how and for what purpose the asset will be used and if the lessor has substantive substitution rights. This evaluation may require significant judgment. (h) REVENUE RECOGNITION––Revenues are recognized when our customer obtains control of promised goods or services in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under 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 are recognized when the customer obtains control of our product, which occurs at a point in time, typically upon delivery to 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 less or the amount is immaterial. We treat shipping and handling costs performed after a customer obtains control of the product as a fulfillment cost. We have identified one performance obligation in our contracts with customers which is the delivery of product to our customers. The transaction price is recognized in full when we deliver the product to our customer, which is the point at which we have satisfied our performance obligation. (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: Reserves for Discounts and Allowances Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the international markets in which we operate. Our process for estimating reserves established for these variable consideration components do not differ materially from our historical practices. Product revenue reserves, which are classified as a reduction in product revenues, are generally characterized in the following categories: discounts, contractual adjustments and returns. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). Our estimates of reserves established for variable consideration typically utilize the most likely method and reflect our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment. For additional information on our revenues, please read Note 2, Revenues, to these condensed consolidated financial statements. (i) SHIPPING AND HANDLING FEES––Shipping and handling fees, if billed to customers, are included in product sales. Shipping and handling costs associated with inbound and outbound freight are expensed as incurred and included in freight and shipping expense. (j) ADVERTISING––Advertising costs are charged to operations when incurred. We incur minimal advertising expenses. (k) RESEARCH AND DEVELOPMENT COSTS––Research and development costs are expensed as incurred. Research and development expense primarily consists of product development, third-party contractors, salaries and materials. (l) INCOME TAXES––Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases. Deferred tax assets and liabilities are measured using enacted rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. In addition, tax benefits related to positions considered uncertain are recognized only when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts. As of September 30, 2023 and December 31, 2022, the Company has recorded a full valuation allowance against its deferred tax assets. (m) NET LOSS PER COMMON SHARE–– Basic and fully diluted net loss per common share is computed using a simple weighted average of common shares outstanding during the periods presented, as outstanding warrants to purchase 13,733,117 shares of common stock were antidilutive for the three and nine months ended September 30, 2023, and warrants to purchase 2,045,846 shares of common stock were antidilutive for the three and nine months ended September 30, 2022. Additionally, outstanding options to purchase 790,945 shares of common stock were antidilutive for the three and nine months ended September 30, 2023, and outstanding options to purchase 425,646 shares of common stock were antidilutive for the three and nine months ended September 30, 2022 and therefore also excluded. (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: (n) STOCK-BASED COMPENSATION––The Company periodically awards stock to employees, directors, and consultants. In the case of employees and consultants, an expense is recognized equal to the fair value of the stock determined using the closing trading price of the stock on the award date. With respect to directors, the Company accrues stock compensation expense on a quarterly basis based on the Company’s historical director compensation policies, and each quarter recognizes such expense based on the trading price of the common stock during such quarter. This expense is then trued up at the time the shares are issued to directors based on the trading price at the time of issuance. The Company periodically issues stock options under its 2021 Equity Incentive Plan. The Company uses the Black-Scholes valuation method to estimate the fair value of stock options at grant date. Compensation expense is recognized on the straight-line basis over the requisite service period, which is generally the vesting period. (o) FAIR VALUE MEASUREMENTS AND DISCLOSURES––The Fair Value Measurements and Disclosures topic of the Accounting Standards Codification (“ASC”) requires companies to determine fair value based on the price that would be received to sell the asset or paid to transfer the liability to a market participant. The Fair Value Measurements and Disclosures topic emphasizes that fair value is a market-based measurement, not an entity-specific measurement. The guidance requires that assets and liabilities carried at fair value be classified and disclosed in one of the following categories: ● Level 1: Quoted market prices in active markets for identical assets or liabilities. ● Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data. ● Level 3: Unobservable inputs that are not corroborated by market data. We have no assets or liabilities required to have their fair value measured on a recurring basis at September 30, 2023 and December 31, 2022. Long-lived assets are measured at fair value on a non-recurring basis and are subject to fair value adjustments when there is evidence of impairment. For short-term classes of our financial instruments, which include cash and cash equivalents, accounts receivable and accounts payable, and which are not reported at fair value, the carrying amounts approximate fair value due to their short-term nature. (p) USE OF ESTIMATES––The preparation of condensed 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 condensed consolidated financial statements and accompanying notes. The Company’s most significant estimates relate to inventory obsolescence, stock-based compensation and warrant liability valuation. 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. (q) RECENT ACCOUNTING PRONOUNCEMENTS––In June 2016, - , In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU 2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company has adopted this standard as of January 1, 2023, and determined no material impact on its condensed consolidated financial statements. (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: (r) WARRANTS––The Company accounts for its warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants considering the authoritative guidance in ASC 480 , , , , (s) LIQUIDITY AND GOING CONCERN––For the three and nine months ended September 30, 2023, the Company incurred a net loss of approximately $ 4,771,000 14,415,000 78,214,000 For nine months ended September 30, 2023, the Company’s operations used approximately $ 11,890,000 1,802,000 We intend to continue to raise such capital through the sale of equity securities from time to time, the issuance of debt securities, the sale or licensing of existing assets or assets in development, or from other non-dilutive funding mechanisms. Our ability to obtain such additional capital will likely be subject to various factors, including our overall business performance and market conditions. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our Common Stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings also could have a material and adverse effect on the price of our Common Stock. Our condensed consolidated financial statements for the nine months ended September 30, 2023, were prepared on the basis of a going concern, which contemplates that we will be able to realize assets and discharge liabilities in the normal course of business. Our ability to continue as a going concern is dependent upon the availability of equity financing as noted above. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties. |
Note 3 - Revenues
Note 3 - Revenues | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | (3) REVENUES: The Company operates in one 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 - - Trappsol® HPB $ 342,184 $ 337,474 $ 485,412 $ 759,079 Trappsol® Fine Chemical 152,135 113,394 267,338 422,418 Aquaplex® 60 - 9,922 816 Other 1,098 1,299 2,334 6,644 Total revenues $ 495,477 $ 452,167 $ 765,006 $ 1,188,957 Substantially all of our Aquaplex® sales for the three and nine months ended September 30, 2023 and 2022 were to one three |
Note 4 - Major Customers and Su
Note 4 - Major Customers and Suppliers | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Major Customers and Suppliers Disclosure [Text Block] | (4) 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 September 30, 2023, two three two three Substantially all inventory purchases were from four vendors in 2023 and 2022; however, the Company believes it can maintain purchases at similar levels through other readily available vendors in the marketplace. The Company maintains vendors both domestically and internationally. The Company has relationships with four laboratories that can manufacture our Aquaplex® line of products. There are multiple sources for our Trappsol® products. For the nine months ended September 30, 2023, the product mix of our revenues consisted of 99% basic natural and chemically modified cyclodextrins and 1% cyclodextrin complexes. For the three months ended September 30, 2023, the product mix of our revenues consisted entirely of basic natural and chemically modified cyclodextrins. For the three and nine months ended September 30, 2022 the product mix of our revenues consisted entirely of basic natural and chemically modified cyclodextrins. |
Note 5 - Note Payable
Note 5 - Note Payable | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | (5) NOTE PAYABLE: On May 4, 2020, the Company’s wholly owned subsidiary, Cyclodextrin Technologies Development, Inc., borrowed $158,524 from BBVA USA under the Paycheck Protection Program (PPP) which was established under the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”). The loan matured on May 4, 2022 and bore interest at a rate of 1% per annum, payable monthly commencing on September 5, 2021. Under the Paycheck Protection Program, because the loan was used to fund certain qualifying expenses as described in the CARES Act, the full amount of the loan, including accrued interest was forgiven in March 2022. As a result, the balance forgiven is presented separately as gain on the forgiveness of PPP loan in the accompanying condensed consolidated statement of operations. |
Note 6 - Leases
Note 6 - Leases | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | (6) LEASES The Company entered into an operating lease in January 2023 for office and warehouse space, which has a lease term expiring in January 2026, with an option to extend for an additional three |
Note 7 - Equity Transactions
Note 7 - Equity Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | (7) EQUITY TRANSACTIONS: On March 3, 2023, following the approval of the Company’s stockholders at a special meeting, the Company’s Articles of Incorporation were amended to increase the number of authorized shares of common stock from 20,000,000 to 50,000,000. The Company accrues stock compensation expense over the period earned for employees and board members. Stock compensation expense for board members is included in “Board of Directors fees and costs” on our condensed consolidated statement of operations, and stock compensation expense for officers and employees that are not board members is included in “Personnel” on our condensed consolidated statement of operations. In the three and nine month ended September 30, 2023, the Company recognized compensation expense of $75,460 and $185,635 to board members, in addition to $30,750 of accrued stock compensation as of December 31, 2022, and issued 55,485 shares to board members in the three months ended September 30, 2023. In the three and nine months ended September 30, 2022, the Company issued 16,017 and 39,083 shares to board members with a value of $30,752 and $102,512, respectively, at the time of issuance. Compensation expense for the 11,327 shares issued to board members with a value of $41,004 at the time of issuance had been accrued as of December 31, 2021. The Company did not On January 3, 2023, the Company sold to an institutional investor in a registered direct offering 930,000 shares of common stock at a purchase price per share of $1.61, and prefunded warrants to purchase up to an aggregate of 1,678,696 shares of common stock at a purchase price of $1.61 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.0001 per share and remain exercisable until exercised in full. In a concurrent private placement, the Company also issued to the investor Series A-1 warrants to purchase up to 2,608,696 shares of common stock at an exercise price of $1.36 per share, exercisable for a period of five three (7) EQUITY TRANSACTIONS: The Company classified the fair value of the warrants as equity because they are indexed to its own stock and meet the conditions necessary for equity classification in accordance with the guidance in ASC Subtopic 815-40 on derivatives and hedging. H.C. Wainwright & Co., LLC acted as placement agent to the Company in connection with the registered direct offering and concurrent private placement and was paid a cash fee equal to 7.5% of the gross proceeds of the offering, a management fee equal to 1.0% of the gross proceeds of the offering, and was reimbursed by the Company for its non-accountable expenses in the amount of $35,000, for fees and expenses of its legal counsel, for other out-of-pocket expenses in the amount of $50,000, and for its clearing expenses in the amount of $15,950. The Company also issued to designees of the placement agent five On January 25, 2023, the investor exercised a portion of its pre-funded warrants and acquired 400,696 shares of common stock for an aggregate exercise price of $40, and on February 27, 2023, the investor exercised an additional portion of its pre-funded warrants and acquired 741,000 shares of common stock for an aggregate exercise price of $74. On April 3, 2023, the investor exercised the remaining balance of pre-funded warrants and acquired 537,000 shares of common stock for an aggregate exercise price of $54. On April 20, 2023, the Company, completed a private placement of its securities priced at-the-market under the rules of The Nasdaq Stock Market, Inc., to a group of accredited investors that included several directors of the Company and members of management and their affiliates. Investors in the private placement purchased 1,562,883 shares of common and were issued warrants to purchase 1,562,883 shares of common. The purchase price for one share of common stock and a Warrant to purchase one share of common stock was $0.835. The Warrants have an exercise price of $0.71 and have a term of seven On May 2, 2023, the Company completed the private placement of its securities to Rafael Holdings, Inc. (“Rafael Holdings”), a Delaware corporation, in which it purchased 2,514,970 shares of common stock, and a warrant to purchase an additional 2,514,970 shares of common stock for an aggregate purchase price of $2,100,000. The Warrant has an exercise price of $0.71 per share, and is exercisable for the seven On August 1, 2023, the Company completed an additional private placement of its securities to Rafael Holdings pursuant to a securities purchase agreement between the Company and Rafael Holdings dated June 1, 2023. Rafael Holdings purchased 4,000,000 shares of common stock and a seven As of September 30, 2023, the Company had warrants outstanding to purchase 13,733,117 shares of common stock at exercise prices ranging from $0.71 to $65.00 per share that expire at various dates through 2030. In addition, there are currently outstanding seven-year |
Note 8 - Income Taxes
Note 8 - Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | (8) INCOME TAXES: The Company reported a net loss for the nine months ended September 30, 2023 and 2022. The Company increased its deferred tax asset valuation allowance rather than recognize an income tax benefit. |
Note 9 - Equity Incentive Plan
Note 9 - Equity Incentive Plan | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | (9) EQUITY INCENTIVE PLAN: On August 29, 2019, the Company’s stockholders approved the Company’s 2019 Omnibus Equity Incentive Plan at a special meeting of stockholders (the “Incentive Plan”). The Incentive Plan provides for the issuance of up to 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 no On June 24, 2021 , , ten , During the three months ended September 30, 2023, the Company granted options to purchase 6,700 shares of common stock to a non-employee director, with an exercise price of $1.26. During the nine months ended September 30, 2023, the Company granted options to purchase (i) an aggregate of 321,631 shares of common stock at exercise prices of $1.28 per share to its officers and employees, (ii) 2,500 shares of common to three employees, with an exercise price of $1.28, (iii) 3,350 shares of common stock to each of the five non-employee directors, with an exercise price of $1.28, and (iv) 113,400 shares of common stock at exercise price of $1.17 to $1.37 per share to a nonemployee and members of the board of directors. Under the option agreements, the options vest either (i) immediately or (ii) 50% at six months and fully vested at twelve months, and have a 10-year term. The options granted during the three and nine months ended September 30, 2023 were valued using the Black Scholes option pricing model using the following assumptions: (i) expected term of 5.00 to 6.25 years; (ii) risk free interest rate of 3.9% - 4.2%; (iii) expected volatility of 101.24% to 103.11%; and (iv) dividend yield of 0.0%. The weighted-average grant date fair value of the options issued by the Company during the three and nine months ended September 30, 2023 ranged from $0.97 to $0.92 per share. |
Note 10 - Net Loss Per Share
Note 10 - Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | (10) NET LOSS PER SHARE: The following table sets forth the computation of basic and diluted earnings per common share. Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator Net loss $ (4,771,353 ) $ (4,246,880 ) $ (14,414,893 ) $ (10,470,461 ) Denominator Weighted-average common shares outstanding, basic and diluted 16,191,723 8,447,630 14,394,920 8,428,074 Net loss per share, basic and diluted (0.29 ) $ (.50 ) (1.00 ) $ (1.24 ) (10) NET LOSS PER SHARE: The Company reported a net loss for the three and nine months ended September 30, 2023 and 2022, therefore, the basic and diluted net loss per share are the same in the respective periods because of the inclusion of potential common shares would have an anti-dilutive effect. Potential shares of common stock that are excluded from the computation of diluted weighted-average shares outstanding are as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Stock options 790,945 425,646 790,945 425,646 Warrants 13,733,117 2,045,846 13,733,117 2,045,846 |
Note 11 - Purchase Commitments
Note 11 - Purchase Commitments | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | (11) PURCHASE COMMITMENTS: In connection with an agreement executed in January 2022 with Ashland, Inc., the Company committed to purchase minimum amounts of goods used in its normal operations based on completion of certain milestones. The first milestone was met during the first quarter of 2023, and $980,000 of goods were purchased and received. In the second quarter of 2023, the Company was invoiced for the second milestone, although goods have not yet been received. Future annual minimum purchases remaining under the agreement are $980,000. |
Note 12 - Subsequent Events
Note 12 - Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | (12) SUBSEQUENT EVENTS: Early Warrant Exercise Transaction On October 20, 2023, the Company entered into a securities purchase agreement (“Purchase Agreement”) with certain accredited investors (the “Investors”) in which it raised approximately $2.4 million in a private offering. The Investors own vested warrants to purchase of approximately 3.4 million shares of the Company’s common stock at an exercise price of $0.71 per share (the “Original Warrants”), which they purchased in private offerings in April and May 2023. In the Offering, the Investors exercised their Original Warrants in full on or prior to October 20, 2023 in consideration of receipt of new warrants (“New Warrants”) with an exercise price equal to $0.95 per share, to purchase 110% of the number of shares of the Company’s common stock covered under the Original Warrants. The New Warrants will be exercisable for cash only and have a term of four Nasdaq Delisting Notice On May 14, 2023, the Company received a letter from the Listing Qualifications Staff (“Nasdaq Staff”) stating that Company was not in compliance with its rule regarding minimum stockholders’ equity (“Stockholders Equity Rule” or “Rule”) of $2.5 million as of its quarter ended March 31, 2023. Pursuant to the Nasdaq Listing Rules, the Company submitted a compliance plan to Nasdaq to regain compliance with this Rule. On August 1, 2023, the Company completed a private placement of its securities in which it raised $5 million (“Rafael Financing”) from Rafael Holdings, a significant shareholder. On August 1, 2023, Pursuant to Nasdaq Listing Rules, the Company must evidence compliance with the Stockholders’ Equity Rule upon the filing of this Quarterly Report on Form 10-Q for the period ended September 30, 2023. The Company does not meet the requirement of having $2.5 million in stockholders’ equity as of September 30, 2023 and it may receive a delisting notice from Nasdaq. The Company believes that it will be in compliance with the Stockholders’ Equity Rule when it closes the Merger with AMTI. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | (a) BASIS OF PRESENTATION––The condensed consolidated financial statements include the Company and its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. The interim condensed consolidated financial statements of the Company included in this Quarterly Report on Form 10-Q, including these notes, are unaudited. In the opinion of management, all adjustments necessary for a fair presentation of the condensed consolidated financial statements have been included. Such adjustments are of a normal, recurring nature. The condensed consolidated financial statements, and these notes, have been prepared in accordance with Generally Accepted Accounting Principles and do not contain certain information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022. The condensed consolidated financial statements should be read in conjunction with that Annual Report on Form 10-K. Results for the interim periods presented are not necessarily indicative of the results that might be expected for the entire fiscal year. |
Cash and Cash Equivalents, Policy [Policy Text Block] | (b) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original purchased maturity of three months or less. |
Receivable [Policy Text Block] | (c) ACCOUNTS RECEIVABLE––Accounts receivable are unsecured and non-interest bearing and stated at the amount we expect to collect from outstanding balances. Customer account balances with invoices dated over 90 days old are considered past due. The Company does not accrue interest on past due accounts. Customer payments are allocated to the specific invoices identified on the customer’s remittance advice or, if unspecified, applied to the oldest unpaid invoices. The carrying amount of accounts receivable is reduced by an allowance for credit losses that reflects management’s best estimate of expected credit losses. The Company reviews each customer balance where all or a portion of the balance exceeds 90 days from the invoice date. Based on the Company’s assessment of the customer's current and forecasted 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. The Company has estimated an allowance for doubtful accounts of approximately $10,300 at September 30, 2023 and December 31, 2022. |
Inventory, Policy [Policy Text Block] | (d) INVENTORY AND COST OF PRODUCTS SOLD––Inventory consists of our pharmaceutical drug Trappsol® Cyclo™, cyclodextrin products and chemical complexes purchased for resale recorded at the lower of cost (first-in, first-out) or net realizable value. Cost of products sold includes the acquisition cost of the products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense. The Company records a specific reserve for inventory items that are determined to be obsolete. The reserve for obsolete inventory was approximately $52,900 at September 30, 2023 and December 31, 2022. 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. |
Prepaid Expenses [Policy Text Block] | (e) 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. In addition, advance payments for goods or services for future research and development activities are included as prepaid clinical expenses. Prepaid clinical expenses are expensed as research and development costs as the goods are delivered or the related services are performed. |
Property, Plant and Equipment, Policy [Policy Text Block] | (f) FURNITURE AND EQUIPMENT––Furniture and equipment are recorded at cost, less accumulated depreciation. Depreciation is computed using primarily the straight-line method over the estimated useful lives of the assets (generally three five seven ten |
Lessee, Leases [Policy Text Block] | (g) LEASES––The Company leases office and warehouse space. The Company determines if an arrangement is a lease at inception. Operating leases are included in lease right-of-use (ROU) assets and lease liabilities on the Company’s condensed consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The lease ROU asset also includes any lease payments made and excludes lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. In evaluating contracts to determine if they qualify as a lease, the Company considers factors such as if the Company has obtained substantially all of the rights to the underlying asset through exclusivity, if it can direct the use of the asset by making decisions about how and for what purpose the asset will be used and if the lessor has substantive substitution rights. This evaluation may require significant judgment. |
Revenue [Policy Text Block] | (h) REVENUE RECOGNITION––Revenues are recognized when our customer obtains control of promised goods or services in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under 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 are recognized when the customer obtains control of our product, which occurs at a point in time, typically upon delivery to 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 less or the amount is immaterial. We treat shipping and handling costs performed after a customer obtains control of the product as a fulfillment cost. We have identified one performance obligation in our contracts with customers which is the delivery of product to our customers. The transaction price is recognized in full when we deliver the product to our customer, which is the point at which we have satisfied our performance obligation. (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: Reserves for Discounts and Allowances Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the international markets in which we operate. Our process for estimating reserves established for these variable consideration components do not differ materially from our historical practices. Product revenue reserves, which are classified as a reduction in product revenues, are generally characterized in the following categories: discounts, contractual adjustments and returns. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). Our estimates of reserves established for variable consideration typically utilize the most likely method and reflect our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment. For additional information on our revenues, please read Note 2, Revenues, to these condensed consolidated financial statements. |
Revenue from Contract with Customer, Shipping and Handling Fees, Policy [Policy Text Block] | (i) SHIPPING AND HANDLING FEES––Shipping and handling fees, if billed to customers, are included in product sales. Shipping and handling costs associated with inbound and outbound freight are expensed as incurred and included in freight and shipping expense. |
Advertising Cost [Policy Text Block] | (j) ADVERTISING––Advertising costs are charged to operations when incurred. We incur minimal advertising expenses. |
Research and Development Expense, Policy [Policy Text Block] | (k) RESEARCH AND DEVELOPMENT COSTS––Research and development costs are expensed as incurred. Research and development expense primarily consists of product development, third-party contractors, salaries and materials. |
Income Tax, Policy [Policy Text Block] | (l) INCOME TAXES––Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases. Deferred tax assets and liabilities are measured using enacted rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. In addition, tax benefits related to positions considered uncertain are recognized only when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts. As of September 30, 2023 and December 31, 2022, the Company has recorded a full valuation allowance against its deferred tax assets. |
Earnings Per Share, Policy [Policy Text Block] | (m) NET LOSS PER COMMON SHARE–– Basic and fully diluted net loss per common share is computed using a simple weighted average of common shares outstanding during the periods presented, as outstanding warrants to purchase 13,733,117 shares of common stock were antidilutive for the three and nine months ended September 30, 2023, and warrants to purchase 2,045,846 shares of common stock were antidilutive for the three and nine months ended September 30, 2022. Additionally, outstanding options to purchase 790,945 shares of common stock were antidilutive for the three and nine months ended September 30, 2023, and outstanding options to purchase 425,646 shares of common stock were antidilutive for the three and nine months ended September 30, 2022 and therefore also excluded. |
Share-Based Payment Arrangement [Policy Text Block] | (n) STOCK-BASED COMPENSATION––The Company periodically awards stock to employees, directors, and consultants. In the case of employees and consultants, an expense is recognized equal to the fair value of the stock determined using the closing trading price of the stock on the award date. With respect to directors, the Company accrues stock compensation expense on a quarterly basis based on the Company’s historical director compensation policies, and each quarter recognizes such expense based on the trading price of the common stock during such quarter. This expense is then trued up at the time the shares are issued to directors based on the trading price at the time of issuance. The Company periodically issues stock options under its 2021 Equity Incentive Plan. The Company uses the Black-Scholes valuation method to estimate the fair value of stock options at grant date. Compensation expense is recognized on the straight-line basis over the requisite service period, which is generally the vesting period. |
Fair Value Measurement, Policy [Policy Text Block] | (o) FAIR VALUE MEASUREMENTS AND DISCLOSURES––The Fair Value Measurements and Disclosures topic of the Accounting Standards Codification (“ASC”) requires companies to determine fair value based on the price that would be received to sell the asset or paid to transfer the liability to a market participant. The Fair Value Measurements and Disclosures topic emphasizes that fair value is a market-based measurement, not an entity-specific measurement. The guidance requires that assets and liabilities carried at fair value be classified and disclosed in one of the following categories: ● Level 1: Quoted market prices in active markets for identical assets or liabilities. ● Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data. ● Level 3: Unobservable inputs that are not corroborated by market data. We have no assets or liabilities required to have their fair value measured on a recurring basis at September 30, 2023 and December 31, 2022. Long-lived assets are measured at fair value on a non-recurring basis and are subject to fair value adjustments when there is evidence of impairment. For short-term classes of our financial instruments, which include cash and cash equivalents, accounts receivable and accounts payable, and which are not reported at fair value, the carrying amounts approximate fair value due to their short-term nature. |
Use of Estimates, Policy [Policy Text Block] | (p) USE OF ESTIMATES––The preparation of condensed 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 condensed consolidated financial statements and accompanying notes. The Company’s most significant estimates relate to inventory obsolescence, stock-based compensation and warrant liability valuation. 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. |
New Accounting Pronouncements, Policy [Policy Text Block] | (q) RECENT ACCOUNTING PRONOUNCEMENTS––In June 2016, - , In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU 2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company has adopted this standard as of January 1, 2023, and determined no material impact on its condensed consolidated financial statements. |
Warrants [Policy Text Block] | (r) WARRANTS––The Company accounts for its warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants considering the authoritative guidance in ASC 480 , , , , |
Liquidity [Policy Text Block] | (s) LIQUIDITY AND GOING CONCERN––For the three and nine months ended September 30, 2023, the Company incurred a net loss of approximately $ 4,771,000 14,415,000 78,214,000 For nine months ended September 30, 2023, the Company’s operations used approximately $ 11,890,000 1,802,000 We intend to continue to raise such capital through the sale of equity securities from time to time, the issuance of debt securities, the sale or licensing of existing assets or assets in development, or from other non-dilutive funding mechanisms. Our ability to obtain such additional capital will likely be subject to various factors, including our overall business performance and market conditions. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our Common Stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings also could have a material and adverse effect on the price of our Common Stock. Our condensed consolidated financial statements for the nine months ended September 30, 2023, were prepared on the basis of a going concern, which contemplates that we will be able to realize assets and discharge liabilities in the normal course of business. Our ability to continue as a going concern is dependent upon the availability of equity financing as noted above. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties. |
Note 3 - Revenues (Tables)
Note 3 - Revenues (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 - - Trappsol® HPB $ 342,184 $ 337,474 $ 485,412 $ 759,079 Trappsol® Fine Chemical 152,135 113,394 267,338 422,418 Aquaplex® 60 - 9,922 816 Other 1,098 1,299 2,334 6,644 Total revenues $ 495,477 $ 452,167 $ 765,006 $ 1,188,957 |
Note 10 - Net Loss Per Share (T
Note 10 - Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator Net loss $ (4,771,353 ) $ (4,246,880 ) $ (14,414,893 ) $ (10,470,461 ) Denominator Weighted-average common shares outstanding, basic and diluted 16,191,723 8,447,630 14,394,920 8,428,074 Net loss per share, basic and diluted (0.29 ) $ (.50 ) (1.00 ) $ (1.24 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Stock options 790,945 425,646 790,945 425,646 Warrants 13,733,117 2,045,846 13,733,117 2,045,846 |
Note 1 - Organization and Des_2
Note 1 - Organization and Description of Business (Details Textual) - AMTI [Member] shares in Millions | Sep. 21, 2023 USD ($) shares |
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable, Shares | shares | 7.6 |
Business Combination, Agreement Termination Amount for Expenses Incurred | $ | $ 450,000 |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Dec. 31, 2022 | |
Accounts Receivable, Allowance for Credit Loss | $ 10,300 | $ 10,300 | ||||
Inventory Valuation Reserves | $ 52,900 | $ 52,900 | 52,900 | |||
Net loss | (4,771,353) | $ (4,246,880) | (14,414,893) | $ (10,470,461) | ||
Retained Earnings (Accumulated Deficit) | (78,214,272) | (78,214,272) | (63,799,379) | |||
Net Cash Provided by (Used in) Operating Activities | (11,890,144) | $ (12,367,461) | ||||
Cash and Cash Equivalents, at Carrying Value | 1,801,809 | 1,801,809 | $ 1,543,418 | |||
Working Capital Deficit | $ 1,111,000 | $ 1,111,000 | ||||
Warrants To Purchase Common Stock [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 13,733,117 | 2,045,846 | 13,733,117 | 2,045,846 | ||
Share-Based Payment Arrangement, Option [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 790,945 | 425,646 | 790,945 | 425,646 | ||
Computers and Vehicles [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment, Useful Life | 3 years | 3 years | ||||
Computers and Vehicles [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment, Useful Life | 5 years | 5 years | ||||
Machinery and Furniture [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment, Useful Life | 7 years | 7 years | ||||
Machinery and Furniture [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment, Useful Life | 10 years | 10 years |
Note 3 - Revenues (Details Text
Note 3 - Revenues (Details Textual) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Number of Operating Segments | 1 | |||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | ||||
Number of Major Customers | 2 | 2 | 3 | 3 |
Trappsol Cyclo [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member] | ||||
Number of Major Customers | 1 | |||
Aquaplex [Member] | Customer Concentration Risk [Member] | Revenue Benchmark [Member] | ||||
Number of Major Customers | 3 | 1 | 3 |
Note 3 - Revenues - Revenues by
Note 3 - Revenues - Revenues by Product (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Total revenues | $ 495,477 | $ 452,167 | $ 765,006 | $ 1,188,957 |
Trappsol Cyclo [Member] | ||||
Total revenues | 342,184 | 337,474 | 485,412 | 759,079 |
Trappsol HPB [Member] | ||||
Total revenues | 152,135 | 113,394 | 267,338 | 422,418 |
Aquaplex [Member] | ||||
Total revenues | 60 | 0 | 9,922 | 816 |
Product and Service, Other [Member] | ||||
Total revenues | $ 1,098 | $ 1,299 | $ 2,334 | $ 6,644 |
Note 4 - Major Customers and _2
Note 4 - Major Customers and Suppliers (Details Textual) - Revenue Benchmark [Member] | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Customer Concentration Risk [Member] | ||||
Number of Major Customers | 2 | 2 | 3 | 3 |
Customer Concentration Risk [Member] | Two Major Customers [Member] | ||||
Concentration Risk, Percentage | 90% | |||
Customer Concentration Risk [Member] | Three Major Customers [Member] | ||||
Concentration Risk, Percentage | 86% | 86% | ||
Customer Concentration Risk [Member] | Four Major Customers [Member] | ||||
Concentration Risk, Percentage | 67% | |||
Product Concentration Risk [Member] | Basic Natural and Chemically Modified Cyclodexterins [Member] | ||||
Concentration Risk, Percentage | 99% | |||
Product Concentration Risk [Member] | Cyclodexterin Complexes [Member] | ||||
Concentration Risk, Percentage | 1% |
Note 5 - Note Payable (Details
Note 5 - Note Payable (Details Textual) | May 04, 2020 USD ($) |
Paycheck Protection Program CARES Act [Member] | |
Proceeds from Issuance of Long-Term Debt | $ 158,524 |
Note 6 - Leases (Details Textua
Note 6 - Leases (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Lease, Right-of-Use Asset, Amortization | $ 12,830 | $ 12,830 | |||
Operating Lease, Expense | $ 7,612 | $ 7,403 | $ 22,759 | $ 22,277 | |
Office Lease [Member] | |||||
Lessee, Operating Lease, Extension Option, Renewal Term | 3 years |
Note 7 - Equity Transactions (D
Note 7 - Equity Transactions (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||
Jun. 01, 2023 | May 02, 2023 | Apr. 20, 2023 | Apr. 03, 2023 | Feb. 27, 2023 | Jan. 25, 2023 | Jan. 03, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Mar. 03, 2023 | Dec. 31, 2022 | Jun. 24, 2021 | |
Common Stock, Shares Authorized | 50,000,000 | 50,000,000 | 50,000,000 | 20,000,000 | 20,000,000 | ||||||||||
Stock Issued During Period, Value, Warrants Exercised | $ 168 | ||||||||||||||
Pre-funded Warrants [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,678,696 | ||||||||||||||
Class of Warrant or Right, Purchase Price of Warrants or Rights (in dollars per share) | $ 1.61 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.0001 | ||||||||||||||
Class of Warrant or Right, Maximum Beneficial Ownership Percent. | 9.99% | ||||||||||||||
Stock Issued During Period, Shares, Warrants Exercised (in shares) | 537,000 | 741,000 | 400,696 | ||||||||||||
Stock Issued During Period, Value, Warrants Exercised | $ 54 | $ 74 | $ 40 | ||||||||||||
Series A-1 Warrants [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,608,696 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.36 | ||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||||||||
Series A-2 Warrants [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,608,696 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.36 | ||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 3 years | ||||||||||||||
Class of Warrant or Right, Maximum Beneficial Ownership Percent. | 4.99% | ||||||||||||||
Warrants Issued to Placement Agent [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 156,522 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.0125 | ||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||||||||||||
Warrants Issued in April 20, 2023 Private Placement [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,562,883 | ||||||||||||||
Class of Warrant or Right, Purchase Price of Warrants or Rights (in dollars per share) | $ 0.835 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.71 | ||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 7 years | ||||||||||||||
Warrants Issued to Rafael Holdings [Member] | Rafael Holdings, Inc. [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 4,000,000 | 2,514,970 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.25 | $ 0.71 | |||||||||||||
Warrants and Rights Outstanding, Term (Year) | 7 years | 7 years | |||||||||||||
Warrants To Purchase Common Stock [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 13,733,117 | 13,733,117 | |||||||||||||
Warrants To Purchase Common Stock [Member] | Minimum [Member] | |||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.71 | $ 0.71 | |||||||||||||
Warrants To Purchase Common Stock [Member] | Maximum [Member] | |||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 65 | $ 65 | |||||||||||||
Warrants to Purchase Units Sold in May 2016 Private Placement [Member] | |||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 7 years | 7 years | |||||||||||||
Warrants to Purchase Units Sold in February 2017 Private Placement [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,641 | 1,641 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 35 | $ 35 | |||||||||||||
Warrants to Purchase Units Sold in October 2017 Private Placement [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,400 | 2,400 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 25 | $ 25 | |||||||||||||
Warrants to Purchase Units Sold in May 2016, February 2017 and October 2017 Private Placement [Member] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 8,082 | 8,082 | |||||||||||||
Warrants and Rights Outstanding | $ 234,861 | $ 234,861 | |||||||||||||
Registered Direct Offering [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 930,000 | ||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.61 | ||||||||||||||
Proceeds from Issuance or Sale of Equity, Net of Issuance Costs | $ 3,700,000 | ||||||||||||||
Stock Issued, Offering Fee, Percentage of Proceeds | 7.50% | ||||||||||||||
Stock Issued, Management Fee, Percentage of Proceeds | 1% | ||||||||||||||
Non-accountable Expense | $ 35,000 | ||||||||||||||
Legal Counsel Expense and Other Out-of-pocket Expense | 50,000 | ||||||||||||||
Clearing Expense | $ 15,950 | ||||||||||||||
Private Placement [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 1,562,883 | ||||||||||||||
Proceeds from Issuance or Sale of Equity | $ 1,305,000 | ||||||||||||||
Private Placement [Member] | Rafael Holdings, Inc. [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 4,000,000 | 2,514,970 | |||||||||||||
Proceeds from Issuance or Sale of Equity | $ 5,000,000 | $ 2,100,000 | |||||||||||||
Board Members [Member] | |||||||||||||||
Share-Based Payment Arrangement, Expense | $ 75,460 | $ 185,635 | $ 10,500 | ||||||||||||
Deferred Compensation Liability, Current and Noncurrent | $ 30,750 | ||||||||||||||
Shares Issued, Shares, Share-Based Payment Arrangement, before Forfeiture (in shares) | 55,485 | 16,017 | 39,083 | 11,327 | |||||||||||
Shares Issued, Value, Share-Based Payment Arrangement, before Forfeiture | $ 30,752 | $ 102,512 | $ 41,004 | ||||||||||||
Employees [Member] | |||||||||||||||
Shares Issued, Shares, Share-Based Payment Arrangement, before Forfeiture (in shares) | 0 | 7,500 | |||||||||||||
Shares Issued, Value, Share-Based Payment Arrangement, before Forfeiture | $ 15,750 | ||||||||||||||
Scientific Advisory Board [Member] | |||||||||||||||
Shares Issued, Shares, Share-Based Payment Arrangement, before Forfeiture (in shares) | 5,000 | ||||||||||||||
Shares Issued, Value, Share-Based Payment Arrangement, before Forfeiture | $ 10,500 |
Note 9 - Equity Incentive Plan
Note 9 - Equity Incentive Plan (Details Textual) - $ / shares | 3 Months Ended | 9 Months Ended | |||
Mar. 07, 2023 | Jun. 24, 2021 | Sep. 30, 2023 | Sep. 30, 2023 | Aug. 29, 2019 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 6,700 | 321,631 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0% | ||||
Minimum [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term | 5 years | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 3.90% | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 101.24% | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0.97 | ||||
Maximum [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Term | 6 years 3 months | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 4.20% | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 103.11% | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0.92 | ||||
Officers and Employees [Member] | |||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ 1.28 | ||||
Three Employees [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 2,500 | ||||
Share-Based Payment Arrangement, Option, Exercise Price Range, Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 1.28 | $ 1.28 | |||
Each of Five Non-employee Directors [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 3,350 | ||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ 1.28 | ||||
Share-Based Payment Arrangement, Option [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | ||||
Share-Based Payment Arrangement, Option [Member] | Nonemployees [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 113,400 | ||||
Share-Based Payment Arrangement, Option [Member] | Nonemployees [Member] | Minimum [Member] | |||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ 1.17 | ||||
Share-Based Payment Arrangement, Option [Member] | Nonemployees [Member] | Maximum [Member] | |||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ 1.37 | ||||
The 2019 Omnibus Incentive Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 68,437 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 68,437 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 0 | 0 | |||
The 2019 Omnibus Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | ||||
The 2021 Equity Incentive Plan [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 3,000,000 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 792,100 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,917,331 | 1,917,331 | |||
The 2021 Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 290,569 |
Note 9 - Net Loss Per Share - E
Note 9 - Net Loss Per Share - Earnings Per Share (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Net loss | $ (4,771,353) | $ (4,246,880) | $ (14,414,893) | $ (10,470,461) |
Weighted-average common shares outstanding, basic and diluted (in shares) | 16,191,723 | 8,447,630 | 14,394,920 | 8,428,074 |
BASIC AND DILUTED NET LOSS PER COMMON SHARE (in dollars per share) | $ (0.29) | $ (50) | $ (1) | $ (1.24) |
Note 10 - Net Loss Per Share -
Note 10 - Net Loss Per Share - Antidilutive Securities Weighted Average Shares Outstanding (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Option [Member] | ||||
Antidilutive Securities (in shares) | 790,945 | 425,646 | 790,945 | 425,646 |
Warrant [Member] | ||||
Antidilutive Securities (in shares) | 13,733,117 | 2,045,846 | 13,733,117 | 2,045,846 |
Note 11 - Purchase Commitments
Note 11 - Purchase Commitments (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Sep. 30, 2023 | |
Purchase Commitment, Remaining Minimum Amount Committed | $ 980,000 | |
Ashland, Inc. [Member] | Purchase Commitment [Member] | ||
Purchase Commitment, Goods Purchased During Period. | $ 980,000 |
Note 12 - Subsequent Events (De
Note 12 - Subsequent Events (Details Textual) - USD ($) $ / shares in Units, shares in Millions | Oct. 20, 2023 | Aug. 01, 2023 | Apr. 20, 2023 | Sep. 30, 2023 | May 14, 2023 |
Nasdaq Listing Rule, Minimum Requirement for Stockholders Equity | $ 2,500,000 | $ 2,500,000 | $ 2,500,000 | ||
Subsequent Event [Member] | Original Warrants [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 3.4 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.71 | ||||
Subsequent Event [Member] | New Warrants [Member] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.95 | ||||
Class of Warrant or Right, Percentage of Company's Stock Purchasable | 110% | ||||
Warrants and Rights Outstanding, Term (Year) | 4 years | ||||
Private Placement [Member] | |||||
Proceeds from Issuance or Sale of Equity | $ 1,305,000 | ||||
Private Placement [Member] | Subsequent Event [Member] | |||||
Proceeds from Issuance or Sale of Equity | $ 2,400,000 | ||||
Rafael Private Placement [Member] | |||||
Proceeds from Issuance or Sale of Equity | $ 5,000,000 |