Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Jun. 30, 2024 | Aug. 05, 2024 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0000863894 | |
Entity Registrant Name | VERU INC. | |
Amendment Flag | false | |
Current Fiscal Year End Date | --09-30 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2024 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 1-13602 | |
Entity Incorporation, State or Country Code | WI | |
Entity Tax Identification Number | 39-1144397 | |
Entity Address, Address Line One | 2916 N. Miami Avenue, Suite 1000 | |
Entity Address, City or Town | Miami | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33127 | |
City Area Code | 305 | |
Local Phone Number | 509-6897 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | VERU | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 146,383,920 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Assets | ||
Cash and cash equivalents | $ 29,150,879 | $ 9,625,494 |
Accounts receivable, net | 1,642,063 | 4,506,508 |
Inventories, net | 4,942,246 | 6,697,117 |
Prepaid research and development costs | 1,125,699 | 1,006,252 |
Prepaid expenses and other current assets | 1,615,254 | 1,097,851 |
Total current assets | 38,476,141 | 22,933,222 |
Plant and equipment, net | 1,491,129 | 1,652,732 |
Operating lease right-of-use assets | 3,756,812 | 4,332,473 |
Investments in equity securities | 228,824 | 0 |
Deferred income taxes | 12,479,488 | 12,707,419 |
Goodwill | 6,878,932 | 6,878,932 |
Other assets | 1,320,328 | 1,518,313 |
Total assets | 64,631,654 | 50,023,091 |
Liabilities and Stockholders' Equity | ||
Accounts payable | 3,018,334 | 12,931,172 |
Accrued compensation | 3,385,464 | 990,609 |
Accrued expenses and other current liabilities | 2,191,054 | 1,987,738 |
Residual royalty agreement liability, short-term portion | 986,388 | 864,623 |
Operating lease liability, short-term portion | 1,038,795 | 1,036,590 |
Total current liabilities | 10,620,035 | 17,810,732 |
Residual royalty agreement liability, long-term portion | 8,577,067 | 8,870,136 |
Operating lease liability, long-term portion | 3,074,721 | 3,634,114 |
Other liabilities | 4,739,375 | 29,948 |
Total liabilities | 27,011,198 | 30,344,930 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Preferred stock; no shares issued and outstanding at June 30, 2024 and September 30, 2023 | 0 | 0 |
Common stock, par value $0.01 per share; 308,000,000 shares authorized, 148,567,624 and 93,966,402 shares issued and 146,383,920 and 91,782,698 shares outstanding at June 30, 2024 and September 30, 2023, respectively | 1,485,676 | 939,664 |
Additional paid-in-capital | 330,561,916 | 283,894,830 |
Accumulated other comprehensive loss | (581,519) | (581,519) |
Accumulated deficit | (286,039,012) | (256,768,209) |
Treasury stock, 2,183,704 shares, at cost | (7,806,605) | (7,806,605) |
Total stockholders' equity | 37,620,456 | 19,678,161 |
Total liabilities and stockholders' equity | $ 64,631,654 | $ 50,023,091 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2024 | Sep. 30, 2023 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized (in shares) | 308,000,000 | 308,000,000 |
Common stock, issued (in shares) | 148,567,624 | 93,966,402 |
Common stock, outstanding (in shares) | 146,383,920 | 91,782,698 |
Treasury stock, at cost (in shares) | 2,183,704 | 2,183,704 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net revenues | $ 3,953,870 | $ 3,341,185 | $ 10,229,897 | $ 12,434,946 |
Cost of sales | 2,615,855 | 2,110,567 | 7,063,131 | 6,410,198 |
Gross profit | 1,338,015 | 1,230,618 | 3,166,766 | 6,024,748 |
Operating expenses: | ||||
Research and development | 4,879,024 | 8,787,636 | 9,515,865 | 47,259,464 |
Selling, general and administrative | 7,507,609 | 10,902,916 | 23,389,380 | 41,283,275 |
Provision for credit losses | 0 | 0 | 0 | 3,911,714 |
Impairment of intangible assets | 0 | 0 | 0 | 3,900,000 |
Total operating expenses | 12,386,633 | 19,690,552 | 32,905,245 | 96,354,453 |
Gain on sale of ENTADFI® assets | 110,000 | 4,723,623 | 1,028,372 | 4,723,623 |
Operating loss | (10,938,618) | (13,736,311) | (28,710,107) | (85,606,082) |
Non-operating income (expenses): | ||||
Interest expense | (127,336) | (648,917) | (437,603) | (2,219,840) |
Change in fair value of derivative liabilities | 83,000 | 1,789,000 | 102,000 | 2,319,000 |
Change in fair value of equity securities | (117,620) | 0 | (689,548) | 0 |
Other income, net | 294,122 | 131,133 | 736,440 | 409,059 |
Total non-operating income (expenses) | 132,166 | 1,271,216 | (288,711) | 508,219 |
Loss before income taxes | (10,806,452) | (12,465,095) | (28,998,818) | (85,097,863) |
Income tax expense (benefit) | 162,422 | 57,551 | 271,985 | (77,286) |
Net income (loss) | $ (10,968,874) | $ (12,522,646) | $ (29,270,803) | $ (85,020,577) |
Net loss per basic and diluted common shares outstanding (in dollars per share) | $ (0.07) | $ (0.14) | $ (0.22) | $ (1.02) |
Basic and diluted weighted average common shares outstanding (in shares) | 146,383,169 | 88,266,152 | 131,010,713 | 83,218,748 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Jefferies Sales Agreement [Member] Common Stock [Member] | Jefferies Sales Agreement [Member] Additional Paid-in Capital [Member] | Jefferies Sales Agreement [Member] AOCI Attributable to Parent [Member] | Jefferies Sales Agreement [Member] Retained Earnings [Member] | Jefferies Sales Agreement [Member] Treasury Stock, Common [Member] | Jefferies Sales Agreement [Member] | Lincoln Park Purchase Agreement [Member] Common Stock [Member] | Lincoln Park Purchase Agreement [Member] Additional Paid-in Capital [Member] | Lincoln Park Purchase Agreement [Member] AOCI Attributable to Parent [Member] | Lincoln Park Purchase Agreement [Member] Retained Earnings [Member] | Lincoln Park Purchase Agreement [Member] Treasury Stock, Common [Member] | Lincoln Park Purchase Agreement [Member] | Public Offering [Member] Common Stock [Member] | Public Offering [Member] Additional Paid-in Capital [Member] | Public Offering [Member] AOCI Attributable to Parent [Member] | Public Offering [Member] Retained Earnings [Member] | Public Offering [Member] Treasury Stock, Common [Member] | Public Offering [Member] | Common Stock Purchase Agreement [Member] Common Stock [Member] | Common Stock Purchase Agreement [Member] Additional Paid-in Capital [Member] | Common Stock Purchase Agreement [Member] AOCI Attributable to Parent [Member] | Common Stock Purchase Agreement [Member] Retained Earnings [Member] | Common Stock Purchase Agreement [Member] Treasury Stock, Common [Member] | Common Stock Purchase Agreement [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] Common Stock [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] Additional Paid-in Capital [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] AOCI Attributable to Parent [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] Retained Earnings [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] Treasury Stock, Common [Member] | Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Treasury Stock, Common [Member] | Total |
Balance (in shares) at Sep. 30, 2022 | 82,692,598 | |||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2022 | $ 826,926 | $ 253,974,032 | $ (581,519) | $ (163,615,517) | $ (7,806,605) | $ 82,797,317 | ||||||||||||||||||||||||||||||
Share-based compensation | 0 | 4,845,269 | 0 | 0 | 0 | 4,845,269 | ||||||||||||||||||||||||||||||
Net Income (loss) | $ 0 | 0 | 0 | (38,708,957) | 0 | (38,708,957) | ||||||||||||||||||||||||||||||
Issuance of shares pursuant to share-based awards (in shares) | 114,234 | |||||||||||||||||||||||||||||||||||
Issuance of shares pursuant to share-based awards | $ 1,142 | 255,990 | 0 | 0 | 0 | 257,132 | ||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 82,806,832 | |||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 828,068 | 259,075,291 | (581,519) | (202,324,474) | (7,806,605) | 49,190,761 | ||||||||||||||||||||||||||||||
Balance (in shares) at Sep. 30, 2022 | 82,692,598 | |||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2022 | $ 826,926 | 253,974,032 | (581,519) | (163,615,517) | (7,806,605) | 82,797,317 | ||||||||||||||||||||||||||||||
Net Income (loss) | (85,020,577) | |||||||||||||||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2023 | 91,420,436 | |||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2023 | $ 914,204 | 276,756,250 | (581,519) | (248,636,094) | (7,806,605) | 20,646,236 | ||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 82,806,832 | |||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 828,068 | 259,075,291 | (581,519) | (202,324,474) | (7,806,605) | 49,190,761 | ||||||||||||||||||||||||||||||
Share-based compensation | 0 | 3,837,598 | 0 | 0 | 0 | 3,837,598 | ||||||||||||||||||||||||||||||
Issuance of shares (in shares) | 1,920,013 | |||||||||||||||||||||||||||||||||||
Issuance of shares | $ 19,200 | $ 2,552,351 | $ 0 | $ 0 | $ 0 | $ 2,571,551 | ||||||||||||||||||||||||||||||
Amortization of deferred costs | 0 | (78,677) | 0 | 0 | 0 | (78,677) | ||||||||||||||||||||||||||||||
Net Income (loss) | $ 0 | 0 | 0 | (33,788,974) | 0 | (33,788,974) | ||||||||||||||||||||||||||||||
Issuance of shares pursuant to share-based awards (in shares) | 33,891 | |||||||||||||||||||||||||||||||||||
Issuance of shares pursuant to share-based awards | $ 339 | 79,139 | 0 | 0 | 0 | 79,478 | ||||||||||||||||||||||||||||||
Balance (in shares) at Mar. 31, 2023 | 84,760,736 | |||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2023 | $ 847,607 | 265,465,702 | (581,519) | (236,113,448) | (7,806,605) | 21,811,737 | ||||||||||||||||||||||||||||||
Share-based compensation | 0 | 4,550,832 | 0 | 0 | 0 | 4,550,832 | ||||||||||||||||||||||||||||||
Issuance of shares (in shares) | 800,000 | 859,700 | 5,000,000 | |||||||||||||||||||||||||||||||||
Issuance of shares | $ 8,000 | $ 1,000,000 | $ 0 | $ 0 | $ 0 | $ 1,008,000 | $ 8,597 | $ 846,843 | $ 0 | $ 0 | $ 0 | $ 855,440 | $ 50,000 | $ 4,919,045 | $ 0 | $ 0 | $ 0 | $ 4,969,045 | ||||||||||||||||||
Amortization of deferred costs | 0 | (26,172) | 0 | 0 | 0 | (26,172) | ||||||||||||||||||||||||||||||
Net Income (loss) | $ 0 | 0 | 0 | (12,522,646) | 0 | (12,522,646) | ||||||||||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2023 | 91,420,436 | |||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2023 | $ 914,204 | 276,756,250 | (581,519) | (248,636,094) | (7,806,605) | 20,646,236 | ||||||||||||||||||||||||||||||
Balance (in shares) at Sep. 30, 2023 | 93,966,402 | |||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2023 | $ 939,664 | 283,894,830 | (581,519) | (256,768,209) | (7,806,605) | 19,678,161 | ||||||||||||||||||||||||||||||
Share-based compensation | 0 | 3,406,949 | 0 | 0 | 0 | 3,406,949 | ||||||||||||||||||||||||||||||
Issuance of shares (in shares) | 90,156 | 1,800,000 | 52,708,332 | |||||||||||||||||||||||||||||||||
Issuance of shares | $ 902 | $ 65,649 | $ 0 | $ 0 | $ 0 | $ 66,551 | $ 18,000 | $ 1,643,490 | $ 0 | $ 0 | $ 0 | $ 1,661,490 | $ 527,083 | $ 34,702,332 | $ 0 | $ 0 | $ 0 | $ 35,229,415 | ||||||||||||||||||
Amortization of deferred costs | 0 | (164,313) | 0 | 0 | 0 | (164,313) | ||||||||||||||||||||||||||||||
Net Income (loss) | $ 0 | 0 | 0 | (8,275,981) | 0 | (8,275,981) | ||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2023 | 148,564,890 | |||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2023 | $ 1,485,649 | 323,548,937 | (581,519) | (265,044,190) | (7,806,605) | 51,602,272 | ||||||||||||||||||||||||||||||
Balance (in shares) at Sep. 30, 2023 | 93,966,402 | |||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2023 | $ 939,664 | 283,894,830 | (581,519) | (256,768,209) | (7,806,605) | 19,678,161 | ||||||||||||||||||||||||||||||
Issuance of shares (in shares) | 90,156 | 1,800,000 | ||||||||||||||||||||||||||||||||||
Issuance of shares | $ 67,000 | $ 1,700,000 | ||||||||||||||||||||||||||||||||||
Amortization of deferred costs | $ (164,000) | |||||||||||||||||||||||||||||||||||
Net Income (loss) | (29,270,803) | |||||||||||||||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2024 | 148,567,624 | |||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2024 | $ 1,485,676 | 330,561,916 | (581,519) | (286,039,012) | (7,806,605) | 37,620,456 | ||||||||||||||||||||||||||||||
Balance (in shares) at Dec. 31, 2023 | 148,564,890 | |||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2023 | $ 1,485,649 | 323,548,937 | (581,519) | (265,044,190) | (7,806,605) | 51,602,272 | ||||||||||||||||||||||||||||||
Share-based compensation | 0 | 3,634,171 | 0 | 0 | 0 | 3,634,171 | ||||||||||||||||||||||||||||||
Amortization of deferred costs | 0 | (851) | 0 | 0 | 0 | (851) | ||||||||||||||||||||||||||||||
Net Income (loss) | $ 0 | 0 | 0 | (10,025,948) | 0 | (10,025,948) | ||||||||||||||||||||||||||||||
Balance (in shares) at Mar. 31, 2024 | 148,564,890 | |||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2024 | $ 1,485,649 | 327,182,257 | (581,519) | (275,070,138) | (7,806,605) | 45,209,644 | ||||||||||||||||||||||||||||||
Share-based compensation | 0 | 3,376,406 | 0 | 0 | 0 | 3,376,406 | ||||||||||||||||||||||||||||||
Net Income (loss) | $ 0 | 0 | 0 | (10,968,874) | 0 | (10,968,874) | ||||||||||||||||||||||||||||||
Issuance of shares pursuant to share-based awards (in shares) | 2,734 | |||||||||||||||||||||||||||||||||||
Issuance of shares pursuant to share-based awards | $ 27 | 3,253 | 0 | 0 | 0 | 3,280 | ||||||||||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2024 | 148,567,624 | |||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2024 | $ 1,485,676 | $ 330,561,916 | $ (581,519) | $ (286,039,012) | $ (7,806,605) | $ 37,620,456 |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | |
OPERATING ACTIVITIES | |||||||
Net income (loss) | $ (10,968,874) | $ (8,275,981) | $ (12,522,646) | $ (38,708,957) | $ (29,270,803) | $ (85,020,577) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 203,033 | 199,690 | |||||
Impairment of intangible assets | 0 | 0 | 0 | 3,900,000 | |||
Provision for credit losses | 0 | 0 | 0 | 3,911,714 | |||
Noncash change in right-of-use assets | 575,661 | 556,475 | |||||
Noncash interest expense, net of interest paid | (69,304) | 1,832,092 | |||||
Gain on sale of ENTADFI® assets | (110,000) | (4,723,623) | (1,028,372) | (4,723,623) | |||
Share-based compensation | 10,417,526 | 13,233,699 | |||||
Deferred income taxes | 227,931 | (213,172) | |||||
Change in fair value of derivative liabilities | (83,000) | (1,789,000) | (102,000) | (2,319,000) | |||
Change in fair value of equity securities | 117,620 | 0 | 689,548 | 0 | |||
Provision for obsolete inventory | 1,266,167 | 195,587 | |||||
Other | (2,592) | 290 | |||||
Changes in current assets and liabilities: | |||||||
Decrease (increase) in accounts receivable | 2,864,445 | (4,729,697) | |||||
Decrease in inventories | 488,704 | 845,688 | |||||
(Increase) decrease in prepaid expenses and other assets | (609,130) | 7,030,293 | |||||
Decrease in accounts payable | (5,173,463) | (6,059,390) | |||||
Increase (decrease) in accrued expenses and other liabilities | 2,763,598 | (6,707,614) | |||||
Decrease in operating lease liabilities | (557,188) | (453,809) | |||||
Net cash used in operating activities | (17,316,239) | (78,521,354) | |||||
INVESTING ACTIVITIES | |||||||
Cash proceeds from sale of ENTADFI® assets | 110,000 | 6,000,000 | |||||
Capital expenditures | (95,286) | (452,826) | |||||
Net cash provided by investing activities | 14,714 | 5,547,174 | |||||
FINANCING ACTIVITIES | |||||||
Proceeds from stock option exercises | 3,280 | 336,610 | |||||
Payment of deferred equity financing issuance costs | 0 | (263,757) | |||||
Proceeds from premium finance agreement | 0 | 1,425,174 | |||||
Installment payments on premium finance agreement | (132,975) | (897,422) | |||||
Net cash provided by financing activities | 36,826,910 | 8,996,641 | |||||
Net increase (decrease) in cash | 19,525,385 | (63,977,539) | |||||
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | $ 9,625,494 | $ 80,190,675 | 9,625,494 | 80,190,675 | $ 80,190,675 | ||
CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ 29,150,879 | $ 16,213,136 | 29,150,879 | 16,213,136 | $ 9,625,494 | ||
Supplemental disclosure of cash flow information: | |||||||
Cash paid for interest | 506,907 | 387,748 | |||||
Schedule of non-cash investing and financing activities: | |||||||
Equity securities received for sale of ENTADFI® assets | 918,372 | 0 | |||||
Amortization of deferred costs related to common stock purchase agreement | 164,313 | 104,849 | |||||
Shares issued in connection with common stock purchase agreement | 0 | 1,008,000 | |||||
Right-of-use asset recorded in exchange for lease liabilities | 0 | 264,896 | |||||
Common Stock Purchase Agreement [Member] | |||||||
FINANCING ACTIVITIES | |||||||
Proceeds from sale of shares | 1,661,490 | 3,426,991 | |||||
Public Offering [Member] | |||||||
FINANCING ACTIVITIES | |||||||
Proceeds from sale of shares | 35,228,564 | 0 | |||||
Jefferies Sales Agreement [Member] | |||||||
FINANCING ACTIVITIES | |||||||
Proceeds from sale of shares | 66,551 | 0 | |||||
Stock Purchase Agreement With Frost Gamma Investment Trust FGI [Member] | |||||||
FINANCING ACTIVITIES | |||||||
Proceeds from sale of shares | $ 0 | $ 4,969,045 |
Note 1 - Basis of Presentation
Note 1 - Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block] | Note 1 Basis of Presentation and Significant Accounting Policies The accompanying unaudited interim condensed consolidated financial statements for Veru Inc. (“we,” “our,” “us,” “Veru” or the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting of interim financial information. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the information not not 10 September 30, 2023 September 30, 2023 three nine June 30, 2024 not September 30, 2024 The preparation of our unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments (consisting of only normally recurring adjustments) necessary to present fairly the financial position and results of operations as of the dates and for the periods presented. Principles of consolidation and nature of operations FC2 Condom/FC2 FC2 December 2021. April 19, 2023. 15 three nine June 30, 2024 2023 FC2. Restatement three December 31, 2023, third third No. 1 10 September 30, 2023, April 1, 2024 September 30, 2023 2022. third three nine June 30, 2023. June 30, 2023 three nine June 30, 2023. A summary of the impact of the error on the unaudited condensed consolidated balance sheet as of June 30, 2023 As of June 30, 2023 As Reported Adjustment As Restated Assets Prepaid research and development costs $ 5,532,410 $ (2,016,947 ) $ 3,515,463 Total current assets $ 34,684,629 $ (2,016,947 ) $ 32,667,682 Total assets $ 62,221,029 $ (2,016,947 ) $ 60,204,082 Liabilities and Stockholders' Equity Accounts payable $ 18,118,594 $ (2,174,590 ) $ 15,944,004 Accrued research and development costs $ 1,112,788 $ 924,273 $ 2,037,061 Total current liabilities $ 27,686,180 $ (1,250,317 ) $ 26,435,863 Total liabilities $ 40,808,163 $ (1,250,317 ) $ 39,557,846 Accumulated deficit $ (247,869,464 ) $ (766,630 ) $ (248,636,094 ) Total stockholders' equity $ 21,412,866 $ (766,630 ) $ 20,646,236 Total liabilities and stockholders' equity $ 62,221,029 $ (2,016,947 ) $ 60,204,082 A summary of the impact of the error on the unaudited condensed consolidated statements of operations for the three nine June 30, 2023 Three Months Ended June 30, 2023 As Reported Adjustment As Restated Research and development $ 2,925,171 $ 5,862,465 $ 8,787,636 Total operating expenses $ 13,828,087 $ 5,862,465 $ 19,690,552 Operating loss $ (7,873,846 ) $ (5,862,465 ) $ (13,736,311 ) Loss before income taxes $ (6,602,630 ) $ (5,862,465 ) $ (12,465,095 ) Net loss $ (6,660,181 ) $ (5,862,465 ) $ (12,522,646 ) Net loss per basic and diluted common shares outstanding $ (0.08 ) $ (0.06 ) $ (0.14 ) Nine Months Ended June 30, 2023 As Reported Adjustment As Restated Research and development $ 44,534,153 $ 2,725,311 $ 47,259,464 Total operating expenses $ 93,629,142 $ 2,725,311 $ 96,354,453 Operating loss $ (82,880,771 ) $ (2,725,311 ) $ (85,606,082 ) Loss before income taxes $ (82,372,552 ) $ (2,725,311 ) $ (85,097,863 ) Net loss $ (82,295,266 ) $ (2,725,311 ) $ (85,020,577 ) Net loss per basic and diluted common shares outstanding $ (0.99 ) $ (0.03 ) $ (1.02 ) With respect to the unaudited condensed consolidated statement of cash flows, all adjustments are to line items within operating cash flows and there was no nine June 30, 2023 Nine Months Ended June 30, 2023 As Reported Adjustment As Restated OPERATING ACTIVITIES Net loss $ (82,295,266 ) $ (2,725,311 ) $ (85,020,577 ) Decrease in prepaid expenses and other assets $ 5,780,913 $ 1,249,380 $ 7,030,293 Decrease in accounts payable $ (3,884,800 ) $ (2,174,590 ) $ (6,059,390 ) Decrease in accrued expenses and other current liabilities $ (10,358,135 ) $ 3,650,521 $ (6,707,614 ) Investments in equity securities 825, Financial Instruments Other comprehensive loss three nine June 30, 2024 2023 Recent accounting pronouncements not November 2023, 2023 07, 280 2023 07 September 30, 2025, In December 2023, 2023 09, 740 September 30, 2026, We have reviewed all other recently issued accounting pronouncements and have determined that such standards that are not not not |
Note 2 - Liquidity
Note 2 - Liquidity | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Liquidity Disclosure [Text Block] | Note 2 Liquidity The Company anticipates that we will continue to consume cash and incur losses as we develop and commercialize our drug candidates. Because of the numerous risks and uncertainties associated with the development of pharmaceutical products, the Company is unable to estimate the exact amounts of capital outlays and operating expenditures necessary to fund development of our drug candidates and obtain regulatory approvals. The Company’s future capital requirements will depend on many factors. The Company believes its current cash position and cash expected to be generated from sales of FC2 12 may may may may 3 No. 333 270606 9 9 may 10 December 31, 2023 8 February 27, 2024, 3 no March 1, 2025. 1, 1, may may may may 10 September 30, 2024, 10 December 31, 2023 8 may not 10 September 30, 2024 March 1, 2025, not |
Note 3 - Fair Value Measurement
Note 3 - Fair Value Measurements | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | Note 3 Fair Value Measurements ASC 820 1 3 The three Level 1 Level 2 not Level 3 As of June 30, 2024 September 30, 2023 3 The following table provides a reconciliation of the beginning and ending liability balance associated with embedded derivatives measured at fair value using significant unobservable inputs (Level 3 June 30, 2024 2023 Nine Months Ended June 30, 2024 2023 Beginning balance $ 1,331,000 $ 4,294,000 Change in fair value of derivative liabilities (102,000 ) (2,319,000 ) Ending balance $ 1,229,000 $ 1,975,000 The gain associated with the change in fair value of the embedded derivatives is included as a separate line item on the accompanying unaudited condensed consolidated statements of operations. The liabilities associated with embedded derivatives represent the fair value of the change of control provision in the Residual Royalty Agreement. See Note 8 no FC2 FC2 The following tables present quantitative information about the inputs and valuation methodologies used to determine the fair value of the embedded derivatives classified in Level 3 June 30, 2024 September 30, 2023 Valuation Methodology Significant Unobservable Input June 30, 2024 September 30, 2023 Scenario-Based Estimated change of control dates March 2025 to March 2027 December 2024 to December 2026 Discount rate 18.7% 20.3% 14.1% 15.1% Probability of change of control 20% 90% 20% 90% The Company also has an investment in equity securities consisting of the BWV Preferred Stock. The BWV Preferred Stock was received on October 3, 2023 September 30, 2023 15 825. 3 no no October 3, 2023 ( June 30, 2024 Significant Unobservable Input October 3, 2023 June 30, 2024 Expected volatility 79 % 88 % Expected term (in years) 3.0 2.3 Discount rate 35 % 35 % Probability of dissolution 60 % 85 % Discount for lack of marketability 15 % 13 % Estimating the fair value of the shares of BWV Preferred Stock requires the use of estimates and judgments. Changes in estimates and judgments could result in a significant change in estimate of the fair value and future adjustments. The following table provides a reconciliation of the beginning and ending balance associated with the BWV Preferred Stock measured at fair value for the nine June 30, 2024 Nine Months Ended June 30, 2024 2023 Beginning balance $ — $ — Additions 918,372 — Change in fair value of equity securities (689,548 ) — Ending balance $ 228,824 $ — |
Note 4 - Revenue From Contracts
Note 4 - Revenue From Contracts With Customers | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | Note 4 Revenue from Contracts with Customers The Company generates all its revenue from direct product sales. Revenue from direct product sales is generally recognized when the customer obtains control of the product, which occurs at a point in time, and may The amount of consideration the Company ultimately receives varies depending upon sales discounts, and other incentives that the Company may not Product returns are typically not not The Company’s revenue is from sales of FC2 FC2 three nine June 30, 2023. three Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 FC2 Global public health sector $ 3,402,328 $ 2,478,031 $ 8,447,329 $ 7,249,315 U.S. prescription channel 551,542 863,379 1,782,568 5,172,543 Total FC2 3,953,870 3,341,410 10,229,897 12,421,858 ENTADFI — (225 ) — 13,088 Net revenues $ 3,953,870 $ 3,341,185 $ 10,229,897 $ 12,434,946 The following table presents net revenues by geographic area: Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 United States $ 1,107,009 $ 1,449,883 $ 3,700,727 $ 7,046,518 South Africa — 612,000 1,177,200 1,941,678 Mozambique 1,317,480 * 2,172,840 * Other 1,529,381 1,279,302 3,179,130 3,446,750 Net revenues $ 3,953,870 $ 3,341,185 $ 10,229,897 $ 12,434,946 *Less than 10% The Company’s performance obligations consist mainly of transferring control of products identified in the contracts which occurs either when: i) the product is made available to the customer for shipment; ii) the product is shipped via common carrier; or iii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement. Some of the Company’s contracts require the customer to make advanced payments prior to transferring control of the products. These advanced payments create a contract liability for the Company. The balances of the Company’s contract liability, included in accrued expenses and other current liabilities on the accompanying unaudited condensed consolidated balance sheets, were approximately $333,000 and $105,000 at June 30, 2024 September 30, 2023 |
Note 5 - Accounts Receivable an
Note 5 - Accounts Receivable and Concentration of Credit Risk | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Loans, Notes, Trade and Other Receivables Disclosure [Text Block] | Note 5 Accounts Receivable and Concentration of Credit Risk The Company's standard credit terms vary from 30 120 may 90 The components of accounts receivable consisted of the following at June 30, 2024 September 30, 2023 June 30, September 30, 2024 2023 Trade receivables, gross $ 5,581,096 $ 8,445,370 Less: allowance for credit losses (3,923,857 ) (3,923,857 ) Less: allowance for sales returns and payment term discounts (15,176 ) (15,005 ) Accounts receivable, net $ 1,642,063 $ 4,506,508 At June 30, 2024 September 30, 2023 10% At June 30, 2024 10% September 30, 2023 10% For the three June 30, 2024 10% three June 30, 2023 five 10% For the nine June 30, 2024 10% nine June 30, 2023 two 10% The Company maintains an allowance for credit losses for estimated losses resulting from the inability of its customers to make required payments on accounts receivable. Management determines the allowance for credit losses by identifying troubled accounts and by using historical experience applied to an aging of accounts. Management also periodically evaluates individual customer receivables and considers a customer’s financial condition, credit history, and the current economic conditions. In the case of a bankruptcy filing or other similar event indicating the collectability of specific customer accounts is no may 11 April 18, 2023, nine June 30, 2023. The table below summarizes the change in the allowance for credit losses for the nine June 30, 2024 2023 Nine Months Ended June 30, 2024 2023 Beginning balance $ 3,923,857 $ 12,143 Charges to expense, net of recoveries — 3,911,714 Ending balance $ 3,923,857 $ 3,923,857 Recoveries of accounts receivable previously charged off are recorded when received. In the global public health sector, the Company’s customers are primarily large global agencies, non-government organizations, ministries of health and other governmental agencies, which purchase and distribute FC2 |
Note 6 - Balance Sheet Informat
Note 6 - Balance Sheet Information | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Supplemental Balance Sheet Disclosures [Text Block] | Note 6 Balance Sheet Information Inventories Inventories are valued at the lower of cost or net realizable value. The cost is determined using the first first not not Inventories consisted of the following at June 30, 2024 September 30, 2023 June 30, September 30, 2024 2023 Raw material $ 728,881 $ 1,854,810 Work in process 50,484 112,799 Finished goods 5,610,384 4,913,295 Inventories, gross 6,389,749 6,880,904 Less: inventory reserves (1,447,503 ) (183,787 ) Inventories, net $ 4,942,246 $ 6,697,117 Fixed Assets We record equipment, furniture and fixtures, and leasehold improvements at historical cost. Expenditures for maintenance and repairs are recorded to expense. Depreciation and amortization are primarily computed using the straight-line method. Depreciation and amortization are computed over the estimated useful lives of the respective assets. Leasehold improvements are depreciated on a straight-line basis over the lesser of the remaining lease term or the estimated useful lives of the improvements. Plant and equipment consisted of the following at June 30, 2024 September 30, 2023 Estimated June 30, September 30, Useful Life (in years) 2024 2023 Plant and equipment: Manufacturing equipment 5 - 8 $ 3,005,977 $ 3,008,122 Office equipment, furniture and fixtures 3 - 10 1,478,339 1,471,870 Leasehold improvements 3 - 8 960,694 960,694 Total plant and equipment 5,445,010 5,440,686 Less: accumulated depreciation and amortization (3,953,881 ) (3,787,954 ) Plant and equipment, net $ 1,491,129 $ 1,652,732 Depreciation expense was approximately $65,000 and $53,000 for the three June 30, 2024 2023 nine June 30, 2024 2023 June 30, 2024 September 30, 2023 not not |
Note 7 - Goodwill
Note 7 - Goodwill | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Goodwill Disclosure [Text Block] | Note 7 Goodwill The carrying amount of goodwill at June 30, 2024 September 30, 2023 nine June 30, 2024 2023 |
Note 8 - Debt
Note 8 - Debt | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | Note 8 Debt SWK Residual Royalty Agreement On March 5, 2018, August 2021, In connection with the Credit Agreement, the Company and the Agent also entered into a Residual Royalty Agreement, dated as of March 5, 2018 FC2. FC2 FC2 x FC2 12 For accounting purposes, the $10.0 million advance under the Credit Agreement was allocated between the Credit Agreement and the Residual Royalty Agreement on a relative fair value basis. A portion of the amount allocated to the Residual Royalty Agreement, equal to the fair value of the respective change of control provisions, was allocated to an embedded derivative liability. The derivative liability is adjusted to fair market value at each reporting period. At June 30, 2024 September 30, 2023 June 30, September 30, 2024 2023 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 12,815,552 12,377,949 Less: cumulative payments (4,827,097 ) (4,320,190 ) Residual royalty agreement liability, excluding embedded derivative liability 8,334,455 8,403,759 Add: embedded derivative liability at fair value (see Note 3) 1,229,000 1,331,000 Total residual royalty agreement liability 9,563,455 9,734,759 Residual royalty agreement liability, short-term portion (986,388 ) (864,623 ) Residual royalty agreement liability, long-term portion $ 8,577,067 $ 8,870,136 As the Company has repaid the original principal of $10.0 million advanced in connection with the Credit Agreement and the Residual Royalty Agreement, payments under the Residual Royalty Agreement are classified as interest payments and included in operating activities on the accompanying unaudited condensed consolidated statements of cash flows. The short-term portion of the Residual Royalty Agreement liability represents the aggregate of the estimated quarterly payments on the Residual Royalty Agreement payable during the 12 Interest expense on the accompanying unaudited condensed consolidated statements of operations relates to the accretion of the liability for the Residual Royalty Agreement. The accretion of the liability is based on projected FC2 Premium Finance Agreement On November 1, 2022, eleven December 1, 2022. September 30, 2023 October 2023 June 30, 2024 |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Equity [Text Block] | Note 9 Stockholders Equity Preferred Stock The Company has 5,000,000 authorized shares designated as Class A Preferred Stock with a par value of $0.01 per share. There are 1,040,000 shares of Class A Preferred Stock – Series 1 2 3 4 4 June 30, 2024 September 30, 2023 June 30, 2024 September 30, 2023 three nine June 30, 2024 2023 Shelf Registration Statement In March 2023, 3 No. 333 270606 April 14, 2023. June 30, 2024 10 December 31, 2023 8 February 27, 2024 may 3 No. 333 270606 1A, Common Stock Offering On December 18, 2023, 3 No. 333 270606 Lincoln Park Capital Fund LLC Purchase Agreement On May 2, 2023, may may one not December 13, 2023, 3 No. 333 270606 May 3, 2023, December 13, 2023 Under the Lincoln Park Purchase Agreement, the Company has the right, but not not 1 not not not three 10 4:00 In addition to Regular Purchases and provided that the Company has directed a Regular Purchase in full, the Company in its sole discretion may three may The purchase price of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases and the minimum closing sale price for a Regular Purchase will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction occurring during the business days used to compute the purchase price. The aggregate number of shares that the Company can sell to Lincoln Park under the Lincoln Park Purchase Agreement may no no 5635 During the nine June 30, 2024 June 30, 2024 In consideration for entering into the Lincoln Park Purchase Agreement, concurrently with the execution of the Lincoln Park Purchase Agreement, the Company issued 800,000 shares of the Company’s common stock to Lincoln Park. The shares of common stock issued as consideration were valued at $1.0 million, based on the closing price per share of the Company’s common stock on the date the shares were issued. This amount and related expenses of $57,000, which total approximately $1.1 million, were recorded as deferred costs. The unamortized deferred costs related to the Lincoln Park Purchase Agreement of $870,000 and $1.0 million as of June 30, 2024 September 30, 2023 At-the-Market Sale Agreement On May 12, 2023, may not 3 No. 333 270606 May 12, 2023. During the nine June 30, 2024 June 30, 2024 June 30, 2024 September 30, 2023 As a result of the Company’s failure to timely file the Quarterly Report on Form 10 December 31, 2023 8 February 27, 2024, not |
Note 10 -Share-based Compensati
Note 10 -Share-based Compensation | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | Note 10 Share-based Compensation We allocate share-based compensation expense to cost of sales, selling, general and administrative expense, and research and development expense based on the award holder’s employment function. For the three nine June 30, 2024 2023 Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 Cost of sales $ 103,058 $ 112,515 $ 294,147 $ 263,879 Selling, general and administrative 2,514,816 3,667,599 8,046,144 10,183,510 Research and development 758,532 770,718 2,077,235 2,786,310 Share-based compensation $ 3,376,406 $ 4,550,832 $ 10,417,526 $ 13,233,699 We have issued share-based awards to employees and non-executive directors under the Company’s approved equity plans. Upon the exercise of share-based awards, new shares are issued from authorized common stock. Equity Plans In June 2022, 2022 June 30, 2024 In March 2018, 2018 “2018 March 29, 2022, may 2018 June 30, 2024 2018 In July 2017, 2017 “2017 2017 June 30, 2024 2017 2017 2008 “2008 2008 Stock Options Each option grants the holder the right to purchase from us one three may ten not three June 30, 2024 2023 nine June 30, 2024 2023 The following table outlines the weighted average assumptions for options granted during the three nine June 30, 2024 2023 Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 Weighted Average Assumptions: Expected volatility 109.64 % 104.96 % 108.86 % 101.37 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Risk-free interest rate 4.48 % 3.51 % 4.49 % 3.92 % Expected term (in years) 6.0 6.0 6.0 6.0 Fair value of options granted $ 1.37 $ 1.12 $ 1.22 $ 5.55 During the three nine June 30, 2024 2023 zero The following table summarizes the stock options outstanding and exercisable at June 30, 2024 Weighted Average Remaining Aggregate Number of Exercise Price Contractual Term Intrinsic Shares Per Share (years) Value Outstanding at September 30, 2023 17,367,643 $ 5.28 Granted 2,281,500 $ 1.45 Exercised (2,734 ) $ 1.20 Forfeited and expired (1,050,081 ) $ 8.51 Outstanding at June 30, 2024 18,596,328 $ 4.63 6.62 $ 76,000 Exercisable at June 30, 2024 12,838,518 $ 4.42 5.61 $ — The aggregate intrinsic values in the table above are before income taxes and represent the number of in-the-money options outstanding or exercisable multiplied by the closing price per share of the Company’s common stock on the last trading day of the quarter ended June 30, 2024 The total intrinsic value of options exercised during the nine June 30, 2024 2023 nine June 30, 2024 2023 As of June 30, 2024 Stock Appreciation Rights In connection with the closing of our acquisition of Aspen Park Pharmaceuticals, Inc. on October 31, 2016 October 31, 2018. ten 2017 June 30, 2024 |
Note 11 - Leases
Note 11 - Leases | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | Note 11 Leases The Company has operating leases for its office, manufacturing and warehouse space, and office equipment. The Company’s leases have remaining lease terms of less than two six one October 31, 2023 not not not June 30, 2024 The components of the Company’s lease cost were as follows for the three nine June 30, 2024 2023 Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 Operating lease cost $ 270,629 $ 277,211 $ 808,952 $ 838,112 Short-term lease cost 10,691 10,903 31,611 32,003 Variable lease cost 14,840 33,926 58,642 136,569 Sublease income — (44,844 ) (15,148 ) (134,533 ) Total lease cost $ 296,160 $ 277,196 $ 884,057 $ 872,151 The Company paid cash of $797,000 and $777,000 for amounts included in the measurement of operating lease liabilities during the nine June 30, 2024 2023 The Company’s operating lease right-of-use assets and the related lease liabilities are presented as separate line items on the accompanying unaudited condensed consolidated balance sheets as of June 30, 2024 September 30, 2023 Other information related to the Company’s leases as of June 30, 2024 September 30, 2023 June 30, September 30, 2024 2023 Operating Leases Weighted-average remaining lease term (years) 5.3 6.1 Weighted-average discount rate 7.5 % 7.7 % The Company’s lease agreements do not |
Note 12 - Contingent Liabilitie
Note 12 - Contingent Liabilities | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | Note 12 Contingent Liabilities The testing, manufacturing and marketing of consumer products by the Company and the clinical testing of our product candidates entail an inherent risk that product liability claims will be asserted against the Company. The Company maintains product liability insurance coverage for claims arising from the use of its products. The coverage amount is currently $10.0 million. Legal Proceedings On December 5, 2022, No. 1:22 23960 September 15, 2023 19 March 1, 2021 March 2, 2023 10 20 1934 10b 5 On July 7, 2023, No. 2023 019406 01 On September 1, 2023, No. 2:23 01164 November 8, 2023, On September 28, 2023, No. 2:23 01291 November 8, 2023, On October 9, 2023, No. 1:23 23846 The Ewing Lawsuit, Maglia Lawsuit, Franchi Lawsuit, Renbarger Lawsuit, and Alshourbagy Lawsuit are collectively referred to as the “Shareholder Litigation.” At this time, the Company is unable to estimate potential losses, if any, related to the Shareholder Litigation. License and Purchase Agreements From time to time, we license or purchase rights to technology or intellectual property from third may not not Collaborative Arrangements On January 31, 2022, 2 no The terms of the Lilly Agreement meet the criteria under ASC Topic 808, 808” 808 not not 606, 730, no Resolution of Commercial Dispute A supplier claimed that we owed approximately $10 million for products and services relating to our efforts to commercialize sabizabulin under an EUA. We disputed the amount owed and on February 29, 2024, December 31, 2025 may April 2024 September 2024. December 31, 2025, January 2026. nine June 30, 2024 June 30, 2024 |
Note 13 - Income Taxes
Note 13 - Income Taxes | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | Note 13 Income Taxes The Company accounts for income taxes using the liability method, which requires the recognition of deferred tax assets or liabilities for the tax-effected temporary differences between the financial reporting and tax bases of its assets and liabilities, and for net operating loss (NOL) and tax credit carryforwards. A reconciliation of income tax expense (benefit) and the amount computed by applying the U.S. statutory rate of 21% to loss before income taxes is as follows: Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 (Restated) 2024 2023 (Restated) Income tax benefit at U.S. federal statutory rates $ (2,269,355 ) $ (2,617,670 ) $ (6,089,752 ) $ (17,870,551 ) State income tax benefit, net of federal benefit (175,713 ) (202,682 ) (471,521 ) (1,383,691 ) Non-deductible expenses 30,038 (262,005 ) 291,056 185,564 Effect of stock options exercised 309 — 309 63,849 U.S. research and development tax credit 1,109,784 2,835,378 692,784 415,378 Effect of foreign income tax rates 5,041 406,324 (77,905 ) 307,188 Effect of global intangible low taxed income 302,155 (24,691 ) 302,155 (24,691 ) Change in valuation allowance 1,157,182 (55,884 ) 5,621,937 18,257,505 Other, net 2,981 (21,219 ) 2,922 (27,837 ) Income tax expense (benefit) $ 162,422 $ 57,551 $ 271,985 $ (77,286 ) |
Note 14 - Net Income (Loss) Per
Note 14 - Net Income (Loss) Per Share | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | Note 14 Net Income (Loss) Per Share Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing net income by the weighted average number of common shares outstanding during the period after giving effect to all dilutive potential common shares that were outstanding during the period. Dilutive potential common shares consist of the incremental common shares issuable upon the exercise of stock options and stock appreciation rights. Due to our net loss for the periods presented, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. See Note 10 |
Note 15 - Sale of ENTADFI Asset
Note 15 - Sale of ENTADFI Assets | 9 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Disposal Groups, Including Discontinued Operations, Disclosure [Text Block] | Note 15 Sale of ENTADFI Assets On April 19, 2023, December 2021, April 19, 2023. September 30, 2023, April 19, 2024 “April 2024 September 30, 2024 ( “September 2024 April 2024 On September 29, 2023, September 30, 2023 1 September 29, 2023 2 October 3, 2023 September 29, 2023 October 3, 2023, October 3, 2023 one December 31, 2023. not June 30, 2024 not June 30, 2024 On April 24, 2024, April 2024 not April 29, 2024, April 25, 2024, April 2024 April 19, 2024, may may April 24, 2024 March 31, 2025 not BWV agreed in the Forbearance Agreement to make the following required payments during the Forbearance Period towards the remaining principal balance of the April 2024 1 2 three June 30, 2024 June 30, 2024 April 2024 The Forbearance Agreement does not September 2024 September 30, 2024 The Company determined that it was not June 30, 2024 2023. nine June 30, 2024 |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 9 Months Ended |
Jun. 30, 2024 | Jun. 30, 2024 | |
Insider Trading Arr Line Items | ||
Material Terms of Trading Arrangement [Text Block] | INFORMATION | |
Rule 10b5-1 Arrangement Terminated [Flag] | false | |
Rule 10b5-1 Arrangement Adopted [Flag] | false | |
Non-Rule 10b5-1 Arrangement Terminated [Flag] | false | |
Non-Rule 10b5-1 Arrangement Adopted [Flag] | false |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Consolidation, Policy [Policy Text Block] | Principles of consolidation and nature of operations FC2 Condom/FC2 FC2 December 2021. April 19, 2023. 15 three nine June 30, 2024 2023 FC2. |
Error Corrections [Policy Text Block] | Restatement three December 31, 2023, third third No. 1 10 September 30, 2023, April 1, 2024 September 30, 2023 2022. third three nine June 30, 2023. June 30, 2023 three nine June 30, 2023. A summary of the impact of the error on the unaudited condensed consolidated balance sheet as of June 30, 2023 As of June 30, 2023 As Reported Adjustment As Restated Assets Prepaid research and development costs $ 5,532,410 $ (2,016,947 ) $ 3,515,463 Total current assets $ 34,684,629 $ (2,016,947 ) $ 32,667,682 Total assets $ 62,221,029 $ (2,016,947 ) $ 60,204,082 Liabilities and Stockholders' Equity Accounts payable $ 18,118,594 $ (2,174,590 ) $ 15,944,004 Accrued research and development costs $ 1,112,788 $ 924,273 $ 2,037,061 Total current liabilities $ 27,686,180 $ (1,250,317 ) $ 26,435,863 Total liabilities $ 40,808,163 $ (1,250,317 ) $ 39,557,846 Accumulated deficit $ (247,869,464 ) $ (766,630 ) $ (248,636,094 ) Total stockholders' equity $ 21,412,866 $ (766,630 ) $ 20,646,236 Total liabilities and stockholders' equity $ 62,221,029 $ (2,016,947 ) $ 60,204,082 A summary of the impact of the error on the unaudited condensed consolidated statements of operations for the three nine June 30, 2023 Three Months Ended June 30, 2023 As Reported Adjustment As Restated Research and development $ 2,925,171 $ 5,862,465 $ 8,787,636 Total operating expenses $ 13,828,087 $ 5,862,465 $ 19,690,552 Operating loss $ (7,873,846 ) $ (5,862,465 ) $ (13,736,311 ) Loss before income taxes $ (6,602,630 ) $ (5,862,465 ) $ (12,465,095 ) Net loss $ (6,660,181 ) $ (5,862,465 ) $ (12,522,646 ) Net loss per basic and diluted common shares outstanding $ (0.08 ) $ (0.06 ) $ (0.14 ) Nine Months Ended June 30, 2023 As Reported Adjustment As Restated Research and development $ 44,534,153 $ 2,725,311 $ 47,259,464 Total operating expenses $ 93,629,142 $ 2,725,311 $ 96,354,453 Operating loss $ (82,880,771 ) $ (2,725,311 ) $ (85,606,082 ) Loss before income taxes $ (82,372,552 ) $ (2,725,311 ) $ (85,097,863 ) Net loss $ (82,295,266 ) $ (2,725,311 ) $ (85,020,577 ) Net loss per basic and diluted common shares outstanding $ (0.99 ) $ (0.03 ) $ (1.02 ) With respect to the unaudited condensed consolidated statement of cash flows, all adjustments are to line items within operating cash flows and there was no nine June 30, 2023 Nine Months Ended June 30, 2023 As Reported Adjustment As Restated OPERATING ACTIVITIES Net loss $ (82,295,266 ) $ (2,725,311 ) $ (85,020,577 ) Decrease in prepaid expenses and other assets $ 5,780,913 $ 1,249,380 $ 7,030,293 Decrease in accounts payable $ (3,884,800 ) $ (2,174,590 ) $ (6,059,390 ) Decrease in accrued expenses and other current liabilities $ (10,358,135 ) $ 3,650,521 $ (6,707,614 ) |
Investment, Policy [Policy Text Block] | Investments in equity securities 825, Financial Instruments |
Comprehensive Income, Policy [Policy Text Block] | Other comprehensive loss three nine June 30, 2024 2023 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent accounting pronouncements not November 2023, 2023 07, 280 2023 07 September 30, 2025, In December 2023, 2023 09, 740 September 30, 2026, We have reviewed all other recently issued accounting pronouncements and have determined that such standards that are not not not |
Note 1 - Basis of Presentatio_2
Note 1 - Basis of Presentation and Significant Accounting Policies (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Error Corrections and Prior Period Adjustments [Table Text Block] | As of June 30, 2023 As Reported Adjustment As Restated Assets Prepaid research and development costs $ 5,532,410 $ (2,016,947 ) $ 3,515,463 Total current assets $ 34,684,629 $ (2,016,947 ) $ 32,667,682 Total assets $ 62,221,029 $ (2,016,947 ) $ 60,204,082 Liabilities and Stockholders' Equity Accounts payable $ 18,118,594 $ (2,174,590 ) $ 15,944,004 Accrued research and development costs $ 1,112,788 $ 924,273 $ 2,037,061 Total current liabilities $ 27,686,180 $ (1,250,317 ) $ 26,435,863 Total liabilities $ 40,808,163 $ (1,250,317 ) $ 39,557,846 Accumulated deficit $ (247,869,464 ) $ (766,630 ) $ (248,636,094 ) Total stockholders' equity $ 21,412,866 $ (766,630 ) $ 20,646,236 Total liabilities and stockholders' equity $ 62,221,029 $ (2,016,947 ) $ 60,204,082 Three Months Ended June 30, 2023 As Reported Adjustment As Restated Research and development $ 2,925,171 $ 5,862,465 $ 8,787,636 Total operating expenses $ 13,828,087 $ 5,862,465 $ 19,690,552 Operating loss $ (7,873,846 ) $ (5,862,465 ) $ (13,736,311 ) Loss before income taxes $ (6,602,630 ) $ (5,862,465 ) $ (12,465,095 ) Net loss $ (6,660,181 ) $ (5,862,465 ) $ (12,522,646 ) Net loss per basic and diluted common shares outstanding $ (0.08 ) $ (0.06 ) $ (0.14 ) Nine Months Ended June 30, 2023 As Reported Adjustment As Restated Research and development $ 44,534,153 $ 2,725,311 $ 47,259,464 Total operating expenses $ 93,629,142 $ 2,725,311 $ 96,354,453 Operating loss $ (82,880,771 ) $ (2,725,311 ) $ (85,606,082 ) Loss before income taxes $ (82,372,552 ) $ (2,725,311 ) $ (85,097,863 ) Net loss $ (82,295,266 ) $ (2,725,311 ) $ (85,020,577 ) Net loss per basic and diluted common shares outstanding $ (0.99 ) $ (0.03 ) $ (1.02 ) Nine Months Ended June 30, 2023 As Reported Adjustment As Restated OPERATING ACTIVITIES Net loss $ (82,295,266 ) $ (2,725,311 ) $ (85,020,577 ) Decrease in prepaid expenses and other assets $ 5,780,913 $ 1,249,380 $ 7,030,293 Decrease in accounts payable $ (3,884,800 ) $ (2,174,590 ) $ (6,059,390 ) Decrease in accrued expenses and other current liabilities $ (10,358,135 ) $ 3,650,521 $ (6,707,614 ) |
Note 3 - Fair Value Measureme_2
Note 3 - Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Nine Months Ended June 30, 2024 2023 Beginning balance $ 1,331,000 $ 4,294,000 Change in fair value of derivative liabilities (102,000 ) (2,319,000 ) Ending balance $ 1,229,000 $ 1,975,000 |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | Valuation Methodology Significant Unobservable Input June 30, 2024 September 30, 2023 Scenario-Based Estimated change of control dates March 2025 to March 2027 December 2024 to December 2026 Discount rate 18.7% 20.3% 14.1% 15.1% Probability of change of control 20% 90% 20% 90% |
Fair Value, Assets and Liabilities Measured on Nonrecurring Basis, Valuation Techniques [Table Text Block] | Significant Unobservable Input October 3, 2023 June 30, 2024 Expected volatility 79 % 88 % Expected term (in years) 3.0 2.3 Discount rate 35 % 35 % Probability of dissolution 60 % 85 % Discount for lack of marketability 15 % 13 % |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Nine Months Ended June 30, 2024 2023 Beginning balance $ — $ — Additions 918,372 — Change in fair value of equity securities (689,548 ) — Ending balance $ 228,824 $ — |
Note 4 - Revenue From Contrac_2
Note 4 - Revenue From Contracts With Customers (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 FC2 Global public health sector $ 3,402,328 $ 2,478,031 $ 8,447,329 $ 7,249,315 U.S. prescription channel 551,542 863,379 1,782,568 5,172,543 Total FC2 3,953,870 3,341,410 10,229,897 12,421,858 ENTADFI — (225 ) — 13,088 Net revenues $ 3,953,870 $ 3,341,185 $ 10,229,897 $ 12,434,946 |
Revenue from External Customers by Geographic Areas [Table Text Block] | Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 United States $ 1,107,009 $ 1,449,883 $ 3,700,727 $ 7,046,518 South Africa — 612,000 1,177,200 1,941,678 Mozambique 1,317,480 * 2,172,840 * Other 1,529,381 1,279,302 3,179,130 3,446,750 Net revenues $ 3,953,870 $ 3,341,185 $ 10,229,897 $ 12,434,946 |
Note 5 - Accounts Receivable _2
Note 5 - Accounts Receivable and Concentration of Credit Risk (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block] | June 30, September 30, 2024 2023 Trade receivables, gross $ 5,581,096 $ 8,445,370 Less: allowance for credit losses (3,923,857 ) (3,923,857 ) Less: allowance for sales returns and payment term discounts (15,176 ) (15,005 ) Accounts receivable, net $ 1,642,063 $ 4,506,508 |
Accounts Receivable, Allowance for Credit Loss [Table Text Block] | Nine Months Ended June 30, 2024 2023 Beginning balance $ 3,923,857 $ 12,143 Charges to expense, net of recoveries — 3,911,714 Ending balance $ 3,923,857 $ 3,923,857 |
Note 6 - Balance Sheet Inform_2
Note 6 - Balance Sheet Information (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | June 30, September 30, 2024 2023 Raw material $ 728,881 $ 1,854,810 Work in process 50,484 112,799 Finished goods 5,610,384 4,913,295 Inventories, gross 6,389,749 6,880,904 Less: inventory reserves (1,447,503 ) (183,787 ) Inventories, net $ 4,942,246 $ 6,697,117 |
Property, Plant and Equipment [Table Text Block] | Estimated June 30, September 30, Useful Life (in years) 2024 2023 Plant and equipment: Manufacturing equipment 5 - 8 $ 3,005,977 $ 3,008,122 Office equipment, furniture and fixtures 3 - 10 1,478,339 1,471,870 Leasehold improvements 3 - 8 960,694 960,694 Total plant and equipment 5,445,010 5,440,686 Less: accumulated depreciation and amortization (3,953,881 ) (3,787,954 ) Plant and equipment, net $ 1,491,129 $ 1,652,732 |
Note 8 - Debt (Tables)
Note 8 - Debt (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Debt [Table Text Block] | June 30, September 30, 2024 2023 Residual royalty agreement liability, fair value at inception $ 346,000 $ 346,000 Add: accretion of liability using effective interest rate 12,815,552 12,377,949 Less: cumulative payments (4,827,097 ) (4,320,190 ) Residual royalty agreement liability, excluding embedded derivative liability 8,334,455 8,403,759 Add: embedded derivative liability at fair value (see Note 3) 1,229,000 1,331,000 Total residual royalty agreement liability 9,563,455 9,734,759 Residual royalty agreement liability, short-term portion (986,388 ) (864,623 ) Residual royalty agreement liability, long-term portion $ 8,577,067 $ 8,870,136 |
Note 10 -Share-based Compensa_2
Note 10 -Share-based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 Cost of sales $ 103,058 $ 112,515 $ 294,147 $ 263,879 Selling, general and administrative 2,514,816 3,667,599 8,046,144 10,183,510 Research and development 758,532 770,718 2,077,235 2,786,310 Share-based compensation $ 3,376,406 $ 4,550,832 $ 10,417,526 $ 13,233,699 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 Weighted Average Assumptions: Expected volatility 109.64 % 104.96 % 108.86 % 101.37 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Risk-free interest rate 4.48 % 3.51 % 4.49 % 3.92 % Expected term (in years) 6.0 6.0 6.0 6.0 Fair value of options granted $ 1.37 $ 1.12 $ 1.22 $ 5.55 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Weighted Average Remaining Aggregate Number of Exercise Price Contractual Term Intrinsic Shares Per Share (years) Value Outstanding at September 30, 2023 17,367,643 $ 5.28 Granted 2,281,500 $ 1.45 Exercised (2,734 ) $ 1.20 Forfeited and expired (1,050,081 ) $ 8.51 Outstanding at June 30, 2024 18,596,328 $ 4.63 6.62 $ 76,000 Exercisable at June 30, 2024 12,838,518 $ 4.42 5.61 $ — |
Note 11 - Leases (Tables)
Note 11 - Leases (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 2024 2023 Operating lease cost $ 270,629 $ 277,211 $ 808,952 $ 838,112 Short-term lease cost 10,691 10,903 31,611 32,003 Variable lease cost 14,840 33,926 58,642 136,569 Sublease income — (44,844 ) (15,148 ) (134,533 ) Total lease cost $ 296,160 $ 277,196 $ 884,057 $ 872,151 |
Lessee, Operating Lease [Table Text Block] | June 30, September 30, 2024 2023 Operating Leases Weighted-average remaining lease term (years) 5.3 6.1 Weighted-average discount rate 7.5 % 7.7 % |
Note 13 - Income Taxes (Tables)
Note 13 - Income Taxes (Tables) | 9 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Three Months Ended Nine Months Ended June 30, June 30, 2024 2023 (Restated) 2024 2023 (Restated) Income tax benefit at U.S. federal statutory rates $ (2,269,355 ) $ (2,617,670 ) $ (6,089,752 ) $ (17,870,551 ) State income tax benefit, net of federal benefit (175,713 ) (202,682 ) (471,521 ) (1,383,691 ) Non-deductible expenses 30,038 (262,005 ) 291,056 185,564 Effect of stock options exercised 309 — 309 63,849 U.S. research and development tax credit 1,109,784 2,835,378 692,784 415,378 Effect of foreign income tax rates 5,041 406,324 (77,905 ) 307,188 Effect of global intangible low taxed income 302,155 (24,691 ) 302,155 (24,691 ) Change in valuation allowance 1,157,182 (55,884 ) 5,621,937 18,257,505 Other, net 2,981 (21,219 ) 2,922 (27,837 ) Income tax expense (benefit) $ 162,422 $ 57,551 $ 271,985 $ (77,286 ) |
Note 1 - Basis of Presentatio_3
Note 1 - Basis of Presentation and Significant Accounting Policies (Details Textual) | Jun. 30, 2024 shares |
Series A Convertible Preferred Stock [Member] | |
Investment Owned, Balance, Shares (in shares) | 3,000 |
Note 1 - Basis of Presentatio_4
Note 1 - Basis of Presentation - Schedule of Restatement (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||||
Jun. 30, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Prepaid research and development costs | $ 1,125,699 | $ 3,515,463 | $ 1,125,699 | $ 3,515,463 | $ 1,006,252 | |||||
Total current assets | 38,476,141 | 32,667,682 | 38,476,141 | 32,667,682 | 22,933,222 | |||||
Total assets | 64,631,654 | 60,204,082 | 64,631,654 | 60,204,082 | 50,023,091 | |||||
Accounts payable | 3,018,334 | 15,944,004 | 3,018,334 | 15,944,004 | 12,931,172 | |||||
Accrued research and development costs | 2,037,061 | 2,037,061 | ||||||||
Total current liabilities | 10,620,035 | 26,435,863 | 10,620,035 | 26,435,863 | 17,810,732 | |||||
Total liabilities | 27,011,198 | 39,557,846 | 27,011,198 | 39,557,846 | 30,344,930 | |||||
Accumulated deficit | (286,039,012) | (248,636,094) | (286,039,012) | (248,636,094) | (256,768,209) | |||||
Total stockholders' equity | 37,620,456 | $ 45,209,644 | $ 51,602,272 | 20,646,236 | $ 21,811,737 | $ 49,190,761 | 37,620,456 | 20,646,236 | 19,678,161 | $ 82,797,317 |
Total liabilities and stockholders' equity | 64,631,654 | 60,204,082 | 64,631,654 | 60,204,082 | $ 50,023,091 | |||||
Research and development | 4,879,024 | 8,787,636 | 9,515,865 | 47,259,464 | ||||||
Total operating expenses | 12,386,633 | 19,690,552 | 32,905,245 | 96,354,453 | ||||||
Operating loss | (10,938,618) | (13,736,311) | (28,710,107) | (85,606,082) | ||||||
Loss before income taxes | (10,806,452) | (12,465,095) | (28,998,818) | (85,097,863) | ||||||
Net income (loss) | $ (10,968,874) | $ (10,025,948) | $ (8,275,981) | $ (12,522,646) | $ (33,788,974) | $ (38,708,957) | $ (29,270,803) | $ (85,020,577) | ||
Net loss per basic and diluted common shares outstanding (in dollars per share) | $ (0.07) | $ (0.14) | $ (0.22) | $ (1.02) | ||||||
(Increase) decrease in prepaid expenses and other assets | $ (609,130) | $ 7,030,293 | ||||||||
Decrease in accounts payable | (5,173,463) | (6,059,390) | ||||||||
Increase (decrease) in accrued expenses and other liabilities | $ 2,763,598 | (6,707,614) | ||||||||
Previously Reported [Member] | ||||||||||
Prepaid research and development costs | $ 5,532,410 | 5,532,410 | ||||||||
Total current assets | 34,684,629 | 34,684,629 | ||||||||
Total assets | 62,221,029 | 62,221,029 | ||||||||
Accounts payable | 18,118,594 | 18,118,594 | ||||||||
Accrued research and development costs | 1,112,788 | 1,112,788 | ||||||||
Total current liabilities | 27,686,180 | 27,686,180 | ||||||||
Total liabilities | 40,808,163 | 40,808,163 | ||||||||
Accumulated deficit | (247,869,464) | (247,869,464) | ||||||||
Total stockholders' equity | 21,412,866 | 21,412,866 | ||||||||
Total liabilities and stockholders' equity | 62,221,029 | 62,221,029 | ||||||||
Research and development | 2,925,171 | 44,534,153 | ||||||||
Total operating expenses | 13,828,087 | 93,629,142 | ||||||||
Operating loss | (7,873,846) | (82,880,771) | ||||||||
Loss before income taxes | (6,602,630) | (82,372,552) | ||||||||
Net income (loss) | $ (6,660,181) | $ (82,295,266) | ||||||||
Net loss per basic and diluted common shares outstanding (in dollars per share) | $ (0.08) | $ (0.99) | ||||||||
(Increase) decrease in prepaid expenses and other assets | $ 5,780,913 | |||||||||
Decrease in accounts payable | (3,884,800) | |||||||||
Increase (decrease) in accrued expenses and other liabilities | (10,358,135) | |||||||||
Revision of Prior Period, Adjustment [Member] | ||||||||||
Prepaid research and development costs | $ (2,016,947) | (2,016,947) | ||||||||
Total current assets | (2,016,947) | (2,016,947) | ||||||||
Total assets | (2,016,947) | (2,016,947) | ||||||||
Accounts payable | (2,174,590) | (2,174,590) | ||||||||
Accrued research and development costs | 924,273 | 924,273 | ||||||||
Total current liabilities | (1,250,317) | (1,250,317) | ||||||||
Total liabilities | (1,250,317) | (1,250,317) | ||||||||
Accumulated deficit | (766,630) | (766,630) | ||||||||
Total stockholders' equity | (766,630) | (766,630) | ||||||||
Total liabilities and stockholders' equity | (2,016,947) | (2,016,947) | ||||||||
Research and development | 5,862,465 | 2,725,311 | ||||||||
Total operating expenses | 5,862,465 | 2,725,311 | ||||||||
Operating loss | (5,862,465) | (2,725,311) | ||||||||
Loss before income taxes | (5,862,465) | (2,725,311) | ||||||||
Net income (loss) | $ (5,862,465) | $ (2,725,311) | ||||||||
Net loss per basic and diluted common shares outstanding (in dollars per share) | $ (0.06) | $ (0.03) | ||||||||
(Increase) decrease in prepaid expenses and other assets | $ 1,249,380 | |||||||||
Decrease in accounts payable | (2,174,590) | |||||||||
Increase (decrease) in accrued expenses and other liabilities | $ 3,650,521 |
Note 3 - Fair Value Measureme_3
Note 3 - Fair Value Measurements - Schedule of Reconciliation of Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Inputs, Level 3 [Member] - Embedded Derivative Financial Instruments [Member] - USD ($) | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Balance | $ 1,331,000 | $ 4,294,000 |
Change in fair value of derivative liabilities | (102,000) | (2,319,000) |
Balance | $ 1,229,000 | $ 1,975,000 |
Note 3 - Fair Value Measureme_4
Note 3 - Fair Value Measurements - Schedule of Valuation Approach and Technique (Details) - Fair Value, Inputs, Level 3 [Member] - Embedded Derivative Financial Instruments [Member] - Valuation, Scenario-based [Member] | Jun. 30, 2024 | Sep. 30, 2023 |
Minimum [Member] | Measurement Input, Discount Rate [Member] | ||
Measurement input | 0.187 | 0.141 |
Minimum [Member] | Measurement Input, Probability of Change of Control [Member] | ||
Measurement input | 0.20 | 0.20 |
Maximum [Member] | Measurement Input, Discount Rate [Member] | ||
Measurement input | 0.203 | 0.151 |
Maximum [Member] | Measurement Input, Probability of Change of Control [Member] | ||
Measurement input | 0.90 | 0.90 |
Note 3 - Fair Value Measureme_5
Note 3 - Fair Value Measurements - Schedule of Significant Unobservable Input (Details) - Fair Value, Inputs, Level 3 [Member] - BWV Preferred Stock [Member] | Jun. 30, 2024 yr | Oct. 03, 2023 yr |
Measurement Input, Price Volatility [Member] | ||
Measurement Input | 0.88 | 0.79 |
Measurement Input, Expected Term [Member] | ||
Measurement Input | 2.3 | 3 |
Measurement Input, Discount Rate [Member] | ||
Measurement Input | 0.35 | 0.35 |
Measurement Input, Probability Of Dissolution [Member[ | ||
Measurement Input | 0.85 | 0.60 |
Measurement Input, Discount for Lack of Marketability [Member] | ||
Measurement Input | 0.13 | 0.15 |
Note 3 - Fair Value Measureme_6
Note 3 - Fair Value Measurements - Schedule of Schedule of Reconciliation of Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Inputs, Level 3 [Member] - BWV Preferred Stock [Member] - USD ($) | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Beginning balance | $ 0 | $ 0 |
Additions | 918,372 | 0 |
Change in fair value of equity securities | (689,548) | 0 |
Ending balance | $ 228,824 | $ 0 |
Note 4 - Revenue From Contrac_3
Note 4 - Revenue From Contracts With Customers (Details Textual) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Contract with Customer, Liability, Current | $ 333,000 | $ 105,000 |
Note 4 - Revenue From Contrac_4
Note 4 - Revenue From Contracts With Customers - Schedule of Revenue by Products (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net revenues | $ 3,953,870 | $ 3,341,185 | $ 10,229,897 | $ 12,434,946 |
FC2 Female Condom [Member] | ||||
Net revenues | 3,953,870 | 3,341,410 | 10,229,897 | 12,421,858 |
FC2 Female Condom [Member] | Sales Channel, U.S. Prescription Channel [Member] | ||||
Net revenues | 551,542 | 863,379 | 1,782,568 | 5,172,543 |
FC2 Female Condom [Member] | Global Public Healthcare Sector [Member] | ||||
Net revenues | 3,402,328 | 2,478,031 | 8,447,329 | 7,249,315 |
ENTADFI Capsules [Member] | ||||
Net revenues | $ 0 | $ (225) | $ 0 | $ 13,088 |
Note 4 - Revenue From Contrac_5
Note 4 - Revenue From Contracts With Customers - Schedule of Revenue by Geographical Area (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net revenues | $ 3,953,870 | $ 3,341,185 | $ 10,229,897 | $ 12,434,946 |
UNITED STATES | ||||
Net revenues | 1,107,009 | 1,449,883 | 3,700,727 | 7,046,518 |
SOUTH AFRICA | ||||
Net revenues | 0 | 612,000 | 1,177,200 | 1,941,678 |
MOZAMBIQUE | ||||
Net revenues | 1,317,480 | 2,172,840 | ||
Other Geographical Areas [Member] | ||||
Net revenues | $ 1,529,381 | $ 1,279,302 | $ 3,179,130 | $ 3,446,750 |
Note 5 - Accounts Receivable _3
Note 5 - Accounts Receivable and Concentration of Credit Risk (Details Textual) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 | Jun. 30, 2024 USD ($) | Jun. 30, 2023 | Sep. 30, 2023 | |
The Pill Club [Member] | Unlikely to be Collected Financing Receivable [Member] | |||||
Accounts Receivable, Allowance for Credit Loss | $ 3.9 | $ 3.9 | |||
Customer Concentration Risk [Member] | Current Assets [Member] | |||||
Concentration Risk, Number of Customers | 0 | 0 | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||||
Concentration Risk, Number of Customers | 4 | 3 | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Four Customers [Member] | |||||
Concentration Risk, Percentage | 67% | ||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Three Customers [Member] | |||||
Concentration Risk, Percentage | 71% | ||||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | |||||
Concentration Risk, Number of Customers | 3 | 5 | 3 | 2 | |
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Three Customers [Member] | |||||
Concentration Risk, Percentage | 71% | 56% | |||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Five Customers [Member] | |||||
Concentration Risk, Percentage | 79% | ||||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Two Customers [Member] | |||||
Concentration Risk, Percentage | 56% | ||||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | The Pill Club [Member] | |||||
Concentration Risk, Percentage | 31% |
Note 5 - Accounts Receivable _4
Note 5 - Accounts Receivable and Concentration of Credit Risk - Schedule of Accounts Receivable (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 |
Trade receivables, gross | $ 5,581,096 | $ 8,445,370 | ||
Less: allowance for credit losses | (3,923,857) | (3,923,857) | $ (3,923,857) | $ (12,143) |
Less: allowance for sales returns and payment term discounts | (15,176) | (15,005) | ||
Accounts receivable, net | $ 1,642,063 | $ 4,506,508 |
Note 5 - Accounts Receivable _5
Note 5 - Accounts Receivable and Concentration of Credit Risk - Schedule of Allowance for Credit Losses (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Balance | $ 3,923,857 | $ 12,143 | ||
Charges to expense, net of recoveries | $ 0 | $ 0 | 0 | 3,911,714 |
Balance | $ 3,923,857 | $ 3,923,857 | $ 3,923,857 | $ 3,923,857 |
Note 6 - Balance Sheet Inform_3
Note 6 - Balance Sheet Information (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | |
Depreciation | $ 65,000 | $ 53,000 | $ 197,000 | $ 146,000 | |
Equipment, Furniture, and Leasehold Improvements [Member] | |||||
Deposit Assets | $ 233,000 | $ 233,000 | $ 214,000 |
Note 6 - Balance Sheet Inform_4
Note 6 - Balance Sheet Information - Schedule of Inventories (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Raw material | $ 728,881 | $ 1,854,810 |
Work in process | 50,484 | 112,799 |
Finished goods | 5,610,384 | 4,913,295 |
Inventories, gross | 6,389,749 | 6,880,904 |
Less: inventory reserves | (1,447,503) | (183,787) |
Inventories, net | $ 4,942,246 | $ 6,697,117 |
Note 6 - Balance Sheet Inform_5
Note 6 - Balance Sheet Information - Schedule of Plant and Equipment (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Plant and equipment: | ||
Plant and equipment | $ 5,445,010 | $ 5,440,686 |
Less: accumulated depreciation and amortization | (3,953,881) | (3,787,954) |
Plant and equipment, net | 1,491,129 | 1,652,732 |
Equipment [Member] | ||
Plant and equipment: | ||
Plant and equipment | $ 3,005,977 | 3,008,122 |
Equipment [Member] | Minimum [Member] | ||
Plant and equipment: | ||
Plant and equipment, useful life (Year) | 5 years | |
Equipment [Member] | Maximum [Member] | ||
Plant and equipment: | ||
Plant and equipment, useful life (Year) | 8 years | |
Office Equipment, Furniture and Fixtures [Member] | ||
Plant and equipment: | ||
Plant and equipment | $ 1,478,339 | 1,471,870 |
Office Equipment, Furniture and Fixtures [Member] | Minimum [Member] | ||
Plant and equipment: | ||
Plant and equipment, useful life (Year) | 3 years | |
Office Equipment, Furniture and Fixtures [Member] | Maximum [Member] | ||
Plant and equipment: | ||
Plant and equipment, useful life (Year) | 10 years | |
Leasehold Improvements [Member] | ||
Plant and equipment: | ||
Plant and equipment | $ 960,694 | $ 960,694 |
Leasehold Improvements [Member] | Minimum [Member] | ||
Plant and equipment: | ||
Plant and equipment, useful life (Year) | 3 years | |
Leasehold Improvements [Member] | Maximum [Member] | ||
Plant and equipment: | ||
Plant and equipment, useful life (Year) | 8 years |
Note 7 - Goodwill (Details Text
Note 7 - Goodwill (Details Textual) - USD ($) | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | |
Goodwill | $ 6,878,932 | $ 6,878,932 | |
Goodwill, Period Increase (Decrease) | $ 0 | $ 0 |
Note 8 - Debt (Details Textual)
Note 8 - Debt (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 05, 2018 | Jun. 30, 2024 | Sep. 30, 2023 | Nov. 01, 2022 | |
Credit Agreement [Member] | ||||
Debt Instrument, Face Amount | $ 10,000 | |||
Long-Term Debt | $ 0 | |||
Residual Royalty Financing Agreement [Member] | ||||
Royalty Agreement, Payment, Percentage | 5% | |||
Residual Royalty Financing Agreement [Member] | Scenario, Change of Control or Sale of Business [Member] | ||||
Royalty Agreement, Payment, Percentage | 5% | |||
Royalty Agreement, Payment to Agent | $ 2,000 | |||
Credit Agreement and Residual Royalty Financing Agreement [Member] | ||||
Debt Instrument, Face Amount | $ 10,000 | |||
Debt Instrument, Repaid, Principal | $ 10,000 | |||
Premium Finance Agreement [Member] | ||||
Debt Instrument, Face Amount | $ 1,400 | |||
Debt Instrument, Interest Rate, Stated Percentage | 6.30% | |||
Accrued Liabilities and Other Liabilities | $ 0 | $ 100 |
Note 8 - Debt - Schedule of Res
Note 8 - Debt - Schedule of Residual Royalty Agreement Liability (Details) - USD ($) | Jun. 30, 2024 | Sep. 30, 2023 |
Residual royalty agreement liability, fair value at inception | $ 346,000 | $ 346,000 |
Add: accretion of liability using effective interest rate | 12,815,552 | 12,377,949 |
Less: cumulative payments | (4,827,097) | (4,320,190) |
Residual royalty agreement liability, excluding embedded derivative liability | 8,334,455 | 8,403,759 |
Add: embedded derivative liability at fair value (see Note 3) | 1,229,000 | 1,331,000 |
Total residual royalty agreement liability | 9,563,455 | 9,734,759 |
Residual royalty agreement liability, short-term portion | (986,388) | (864,623) |
Residual royalty agreement liability, long-term portion | $ 8,577,067 | $ 8,870,136 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 14 Months Ended | 15 Months Ended | |||||||||||
Dec. 18, 2023 | Dec. 13, 2023 | May 12, 2023 | May 02, 2023 | Jun. 30, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2024 | Sep. 30, 2023 | |
Preferred Stock, Shares Issued (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Security Offering, Maximum Value of Securities, Shelf Registration | $ 200,000,000 | ||||||||||||||
Security Offering, Remaining Value of Securities, Shelf Registration | $ 35,100,000 | $ 35,100,000 | $ 35,100,000 | $ 35,100,000 | $ 35,100,000 | ||||||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 851 | $ 164,313 | $ 26,172 | $ 78,677 | |||||||||||
Public Offering [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 52,708,332 | ||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 0.72 | ||||||||||||||
Proceeds from Issuance of Common Stock | $ 35,200,000 | ||||||||||||||
Stock Issued During Period, Value, New Issues | 35,229,415 | ||||||||||||||
Lincoln Park Purchase Agreement [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 1,800,000 | 3,025,000 | |||||||||||||
Shares Purchase Agreement, Value, Shares Authorized | $ 50,000,000 | $ 100,000,000 | |||||||||||||
Share Purchase Agreement, Term (Month) | 36 months | ||||||||||||||
Share Purchase Agreement, Value, Minimum Shares to be Sold | 50,000,000 | ||||||||||||||
Shares Purchase Agreement, Shares Authorized (in shares) | 225,000 | ||||||||||||||
Shares Purchase Agreement, Value, Maximum Commitment | $ 2,500,000 | ||||||||||||||
Shares Purchase Agreement, Shares, Maximum Commitment (in shares) | 2,000,000 | ||||||||||||||
Shares Purchase Agreement, Accelerated Purchase Date, Percent Of Trading Volume | 30% | ||||||||||||||
Shares Purchase Agreement, Accelerated Purchase Date, Purchase Price, Percent | 97% | ||||||||||||||
Shares Purchase Agreement, Shares Authorized, Aggregate Maximum (in shares) | 17,678,502 | ||||||||||||||
Shares Purchase Agreement, Shares Authorized, Percentage of Common Shares Oustanding | 19.99% | ||||||||||||||
Stock Issued During Period, Value, New Issues | 1,661,490 | $ 1,008,000 | $ 1,700,000 | $ 3,100,000 | |||||||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 164,000 | ||||||||||||||
Stock Issued During Period, Shares, Issued for Services (in shares) | 800,000 | ||||||||||||||
Stock Issued During Period, Value, Issued for Services | $ 1,000,000 | ||||||||||||||
Deferred Offering Costs | $ 57,000 | ||||||||||||||
Deferred Costs | $ 1,100,000 | ||||||||||||||
Unamortized Debt Issuance Expense | 870,000 | $ 870,000 | 870,000 | $ 870,000 | 870,000 | $ 1,000,000 | |||||||||
Lincoln Park Purchase Agreement [Member] | Shares Required to be Purchased if Closing Price is $6.00 or Above [Member] | |||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 6 | ||||||||||||||
Shares Purchase Agreement, Shares Authorized (in shares) | 250,000 | ||||||||||||||
Lincoln Park Purchase Agreement [Member] | Shares Required to be Purchased if Closing Price is $8.00 or Above [Member] | |||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 8 | ||||||||||||||
Shares Purchase Agreement, Shares Authorized (in shares) | 275,000 | ||||||||||||||
Lincoln Park Purchase Agreement [Member] | Maximum [Member] | |||||||||||||||
Shares Purchase Agreement, Value, Shares Authorized | $ 50,000,000 | $ 100,000,000 | |||||||||||||
Lincoln Park Purchase Agreement [Member] | Minimum [Member] | |||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 0.25 | ||||||||||||||
Lincoln Park Purchase Agreement [Member] | Weighted Average [Member] | |||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.26 | ||||||||||||||
Jefferies Sales Agreement [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 90,156 | 1,367,415 | |||||||||||||
Shares Purchase Agreement, Value, Shares Authorized | $ 75,000,000 | ||||||||||||||
Stock Issued During Period, Value, New Issues | $ 66,551 | $ 67,000 | $ 1,100,000 | ||||||||||||
Deferred Offering Costs | $ 207,000 | ||||||||||||||
Unamortized Debt Issuance Expense | $ 204,000 | $ 204,000 | $ 204,000 | $ 204,000 | $ 204,000 | $ 204,000 | |||||||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 39,609,072 | ||||||||||||||
Shares Purchase Agreement, Sales Commission, Percent | 3% | ||||||||||||||
Preferred Class A [Member] | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | ||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||||
Preferred Stock, Shares Issued (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Preferred Class, Series A-1 [Member] | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 1,040,000 | 1,040,000 | 1,040,000 | 1,040,000 | 1,040,000 | ||||||||||
Preferred Class, Series A-2 [Member] | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 1,500,000 | 1,500,000 | 1,500,000 | 1,500,000 | 1,500,000 | ||||||||||
Preferred Class, Series A-3 [Member] | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 700,000 | 700,000 | 700,000 | 700,000 | 700,000 | ||||||||||
Preferred Class, Series A-4 [Member] | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 548,000 | 548,000 | 548,000 | 548,000 | 548,000 | ||||||||||
Series B Preferred Stock [Member] | |||||||||||||||
Preferred Stock, Shares Authorized (in shares) | 15,000 | 15,000 | 15,000 | 15,000 | 15,000 | ||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.5 | $ 0.5 | $ 0.5 | $ 0.5 | $ 0.5 | ||||||||||
Preferred Stock, Shares Issued (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Preferred Stock [Member] | |||||||||||||||
Stock Issued During Period, Shares, Period Increase (Decrease) (in shares) | 0 | 0 | 0 | 0 |
Note 10 -Share-based Compensa_3
Note 10 -Share-based Compensation (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Oct. 31, 2016 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 31, 2018 | Jul. 31, 2017 | |
Share-Based Payment Arrangement, Expense | $ 3,376,406 | $ 4,550,832 | $ 10,417,526 | $ 13,233,699 | |||
Share Price (in dollars per share) | $ 0.84 | $ 0.84 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 200 | 486,000 | |||||
Proceeds from Stock Options Exercised | $ 3,280 | 336,610 | |||||
Share-Based Payment Arrangement, Option [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 3 years | ||||||
Share-Based Payment Arrangement, Expense | $ 200,000 | $ 300,000 | $ 1,500,000 | $ 1,800,000 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 15,700,000 | $ 15,700,000 | |||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 9 months 18 days | ||||||
Stock Appreciation Rights (SARs) [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ 0.95 | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 50,000 | ||||||
Stock Appreciation Rights (SARs) [Member] | Share-Based Payment Arrangement, Nonemployee [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 140,000 | ||||||
Stock Appreciation Rights (SARs) [Member] | Share-Based Payment Arrangement, Employee [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 50,000 | ||||||
The 2022 Employment Inducement Equity Incentive Plan [Member] | |||||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 4,000,000 | 4,000,000 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 3,967,083 | 3,967,083 | |||||
The 2018 Equity Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 1,685,939 | 1,685,939 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 18,500,000 | ||||||
The 2017 Equity Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 8,405 | 8,405 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | 4,700,000 | ||||||
The 2008 Stock Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 0 |
Note 10 -Share-based Compensa_4
Note 10 -Share-based Compensation - Schedule of Allocated Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based compensation expenses | $ 3,376,406 | $ 4,550,832 | $ 10,417,526 | $ 13,233,699 |
Cost of Sales [Member] | ||||
Share-based compensation expenses | 103,058 | 112,515 | 294,147 | 263,879 |
Selling, General and Administrative Expenses [Member] | ||||
Share-based compensation expenses | 2,514,816 | 3,667,599 | 8,046,144 | 10,183,510 |
Research and Development Expense [Member] | ||||
Share-based compensation expenses | $ 758,532 | $ 770,718 | $ 2,077,235 | $ 2,786,310 |
Note 10 -Share-based Compensa_5
Note 10 -Share-based Compensation - Weighted Average Assumptions (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Expected volatility | 109.64% | 104.96% | 108.86% | 101.37% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Risk-free interest rate | 4.48% | 3.51% | 4.49% | 3.92% |
Expected term (in years) (Year) | 6 years | 6 years | 6 years | 6 years |
Fair value of options granted (in dollars per share) | $ 1.37 | $ 1.12 | $ 1.22 | $ 5.55 |
Note 10 -Share-based Compensa_6
Note 10 -Share-based Compensation - Schedule of Options (Details) | 9 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | |
Outstanding, balance (in shares) | shares | 17,367,643 |
Outstanding, exercise price (in dollars per share) | $ / shares | $ 5.28 |
Granted (in shares) | shares | 2,281,500 |
Granted, exercise price (in dollars per share) | $ / shares | $ 1.45 |
Exercised (in shares) | shares | (2,734) |
Exercised, exercise price (in dollars per share) | $ / shares | $ 1.2 |
Forfeited and expired (in shares) | shares | (1,050,081) |
Forfeited and expired, exercise price (in dollars per share) | $ / shares | $ 8.51 |
Outstanding, balance (in shares) | shares | 18,596,328 |
Outstanding, exercise price (in dollars per share) | $ / shares | $ 4.63 |
Outstanding, remaining contractual term (Year) | 6 years 7 months 13 days |
Outstanding, intrinsic value | $ | $ 76,000 |
Exercisable (in shares) | shares | 12,838,518 |
Exercisable, exercise price (in dollars per share) | $ / shares | $ 4.42 |
Exercisable, remaining contractual term (Year) | 5 years 7 months 9 days |
Exercisable, intrinsic value | $ | $ 0 |
Note 11 - Leases (Details Textu
Note 11 - Leases (Details Textual) - USD ($) | 9 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating Lease, Payments | $ 797,000 | $ 777,000 |
Minimum [Member] | ||
Lessee, Operating Lease, Remaining Lease Term (Year) | 2 years | |
Maximum [Member] | ||
Lessee, Operating Lease, Remaining Lease Term (Year) | 6 years |
Note 11 - Leases - Schedule of
Note 11 - Leases - Schedule of Lease Cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating lease cost | $ 270,629 | $ 277,211 | $ 808,952 | $ 838,112 |
Short-term lease cost | 10,691 | 10,903 | 31,611 | 32,003 |
Variable lease cost | 14,840 | 33,926 | 58,642 | 136,569 |
Sublease income | 0 | (44,844) | (15,148) | (134,533) |
Total lease cost | $ 296,160 | $ 277,196 | $ 884,057 | $ 872,151 |
Note 11 - Leases - Schedule o_2
Note 11 - Leases - Schedule of Operating Leases (Details) | Jun. 30, 2024 | Sep. 30, 2023 |
Weighted-average remaining lease term (years) (Year) | 5 years 3 months 18 days | 6 years 1 month 6 days |
Weighted-average discount rate | 7.50% | 7.70% |
Note 12 - Contingent Liabilit_2
Note 12 - Contingent Liabilities (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Feb. 29, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | |
Research and Development Expense | $ 4,879,024 | $ 8,787,636 | $ 9,515,865 | $ 47,259,464 | ||
Accounts Payable, Current | 3,018,334 | $ 15,944,004 | 3,018,334 | $ 15,944,004 | $ 12,931,172 | |
Other Liabilities, Noncurrent | 4,739,375 | 4,739,375 | $ 29,948 | |||
Damages from Product Defects [Member] | ||||||
Product Liability Contingency, Loss Exposure Not Accrued, Best Estimate | 10,000,000 | |||||
Loss Contingency, License and Purchase Agreements [Member] | ||||||
Loss Contingency Accrual | 0 | 0 | ||||
Loss Contingency, Commercial Dispute [Member] | ||||||
Research and Development Expense | 600,000 | |||||
Loss Contingency, Commercial Dispute [Member] | Research and Development Liability [Member] | ||||||
Accounts Payable, Current | 900,000 | 900,000 | ||||
Other Liabilities, Noncurrent | $ 4,700,000 | $ 4,700,000 | ||||
Loss Contingency, Commercial Dispute [Member] | Product, Sabizabulin Drug [Member] | ||||||
Loss Contingency, Damages Sought, Value | $ 10,000,000 | |||||
Loss Contingency Accrual, Product Liability, Net | 8,300,000 | |||||
Loss Contingency, Commercial Dispute [Member] | Product, Sabizabulin Drug [Member] | Payment Arrangement, Due Upon Execution of Agreement [Member] | ||||||
Loss Contingency Accrual, Product Liability, Net | 2,300,000 | |||||
Loss Contingency, Commercial Dispute [Member] | Product, Sabizabulin Drug [Member] | Payment Arrangement, Monthly Installments,One [Member] | ||||||
Loss Contingency Accrual, Product Liability, Net | $ 3,500,000 | |||||
Product Liability Contingency, Disbursement Period, Estimate, Accrued (Month) | 48 months | |||||
Loss Contingency, Commercial Dispute [Member] | Product, Sabizabulin Drug [Member] | Payment Arrangement, Balance by December 31, 2025 [Member] | ||||||
Loss Contingency Accrual, Product Liability, Net | $ 2,500,000 | |||||
Loss Contingency, Commercial Dispute [Member] | Product, Sabizabulin Drug [Member] | Payment Arrangement, Monthly Installments, Two [Member] | ||||||
Product Liability Contingency, Disbursement Period, Estimate, Accrued (Month) | 24 months |
Note 13 - Income Taxes (Details
Note 13 - Income Taxes (Details Textual) | 9 Months Ended |
Jun. 30, 2024 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21% |
Note 13 - Income Taxes - Schedu
Note 13 - Income Taxes - Schedule of Reconciliation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income tax benefit at U.S. federal statutory rates | $ (2,269,355) | $ (2,617,670) | $ (6,089,752) | $ (17,870,551) |
State income tax benefit, net of federal benefit | (175,713) | (202,682) | (471,521) | (1,383,691) |
Non-deductible expenses | 30,038 | (262,005) | 291,056 | 185,564 |
Effect of stock options exercised | 309 | 0 | 309 | 63,849 |
U.S. research and development tax credit | 1,109,784 | 2,835,378 | 692,784 | 415,378 |
Effect of foreign income tax rates | 5,041 | 406,324 | (77,905) | 307,188 |
Effect of global intangible low taxed income | 302,155 | (24,691) | 302,155 | (24,691) |
Change in valuation allowance | 1,157,182 | (55,884) | 5,621,937 | 18,257,505 |
Other, net | 2,981 | (21,219) | 2,922 | (27,837) |
Income tax expense (benefit) | $ 162,422 | $ 57,551 | $ 271,985 | $ (77,286) |
Note 15 - Sale of ENTADFI Ass_2
Note 15 - Sale of ENTADFI Assets (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Apr. 24, 2024 | Sep. 29, 2023 | Apr. 19, 2023 | Aug. 08, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | |
Proceeds from Sale of Productive Assets | $ 110,000 | $ 6,000,000 | |||||||
Noncash or Part Noncash Divestiture, Amount of Consideration Received | 918,372 | 0 | |||||||
Disposal Group, Not Discontinued Operation, Gain (Loss) on Disposal | $ 110,000 | $ 4,723,623 | 1,028,372 | $ 4,723,623 | |||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement [Member] | |||||||||
Disposal Group, Including Discontinued Operation, Consideration | $ 20,000,000 | ||||||||
Proceeds from Sale of Productive Assets | 6,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement [Member] | Promissory Notes Receivable, Due September 30, 2023 [Member] | |||||||||
Disposal Group, Including Discontinued Operation, Consideration | 4,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement [Member] | Promissory Notes Receivable, Due April 19, 2024 [Member] | |||||||||
Disposal Group, Including Discontinued Operation, Consideration | 5,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement [Member] | Promissory Notes Receivable, Due September 30, 2024 [Member] | |||||||||
Disposal Group, Including Discontinued Operation, Consideration | 5,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement [Member] | Milestone Receivable [Member] | |||||||||
Disposal Group, Including Discontinued Operation, Consideration | 80,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement, Amended [Member] | |||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 1,000 | ||||||||
Preferred Stock, Convertible, Conversion Price (in dollars per share) | $ 0.5254 | ||||||||
Preferred Stock, Convertible, Shares Issuable (in shares) | 5,709,935 | ||||||||
Disposal Group, Not Discontinued Operation, Gain (Loss) on Disposal | $ 1,000,000 | $ 5,700,000 | |||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement, Amended [Member] | BWV Preferred Stock [Member] | |||||||||
Stock Issued During Period, Shares, Purchase of Assets (in shares) | 3,000 | ||||||||
Noncash or Part Noncash Divestiture, Amount of Consideration Received | $ 900,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement, Amended [Member] | Promissory Notes Receivable, Due September 30, 2023 [Member] | |||||||||
Proceeds from Collection of Notes Receivable | 1,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement, Amended [Member] | Promissory Notes Receivable, Due September 30, 2023 [Member] | Note Receivable, Settlement Terms [Member] | |||||||||
Disposal Group, Including Discontinued Operation, Consideration | 4,000,000 | ||||||||
Proceeds from Collection of Notes Receivable | $ 1,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement, Amended [Member] | Promissory Notes Receivable, Due April 19, 2024 [Member] | |||||||||
Proceeds from Collection of Notes Receivable | $ 50,000 | $ 110,000 | |||||||
Notes Receivable, Percentage of Revenues | 15% | ||||||||
Notes Receivable, Percentage of Net Proceeds | 10% | ||||||||
Financing Receivable, before Allowance for Credit Loss | $ 5,000,000 | ||||||||
ENTADFI [Member] | Disposal Group, Disposed of by Sale, Not Discontinued Operations [Member] | BWV Asset Purchase Agreement, Amended [Member] | Promissory Notes Receivable, Due April 19, 2024 [Member] | Subsequent Event [Member] | |||||||||
Proceeds from Collection of Notes Receivable | $ 150,000 |