Cover Page
Cover Page - shares | 6 Months Ended | |
Nov. 30, 2022 | Dec. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Nov. 30, 2022 | |
Entity File Number | 000-49908 | |
Entity Registrant Name | CYTODYN INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 83-1887078 | |
Entity Address, Address Line One | 1111 Main Street | |
Entity Address, Address Line Two | Suite 660 | |
Entity Address, City or Town | Vancouver | |
Entity Address, State or Province | WA | |
Entity Address, Postal Zip Code | 98660 | |
City Area Code | 360 | |
Local Phone Number | 980-8524 | |
Title of 12(b) Security | None | |
No Trading Symbol Flag | true | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 832,970,710 | |
Current Fiscal Year End Date | --05-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001175680 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Nov. 30, 2022 | May 31, 2022 |
Current assets: | ||
Cash | $ 2,403 | $ 4,231 |
Restricted cash | 200 | |
Prepaid expenses | 2,854 | 5,198 |
Prepaid service fees | 1,094 | 1,086 |
Total current assets | 6,551 | 10,515 |
Inventories, net | 17,929 | |
Other non-current assets | 523 | 741 |
Total assets | 7,074 | 29,185 |
Current liabilities: | ||
Accounts payable | 67,187 | 67,974 |
Accrued liabilities and compensation | 5,722 | 8,995 |
Accrued interest on convertible notes | 8,279 | 5,974 |
Accrued dividends on convertible preferred stock | 4,571 | 3,977 |
Convertible notes payable, net | 36,931 | 36,241 |
Total current liabilities | 122,690 | 123,161 |
Long-term liabilities: | ||
Operating leases | 353 | 422 |
Total liabilities | 123,043 | 123,583 |
Commitments and Contingencies (Note 9) | ||
Stockholders' deficit: | ||
Common stock, $0.001 par value; 1,350,000 shares authorized; 825,279 and 720,028 issued, and 824,836 and 719,585 outstanding at November 30, 2022 and May 31, 2022, respectively | 825 | 720 |
Additional paid-in capital | 692,558 | 671,013 |
Accumulated deficit | (809,352) | (766,131) |
Total stockholders' deficit | (115,969) | (94,398) |
Total liabilities and stockholders' deficit | 7,074 | 29,185 |
Series B Convertible Preferred Stock | ||
Stockholders' deficit: | ||
Preferred stock | ||
Series C Convertible Preferred Stock | ||
Current liabilities: | ||
Accrued dividends on convertible preferred stock | 2,184 | 2,014 |
Stockholders' deficit: | ||
Preferred stock | ||
Series D Convertible Preferred Stock | ||
Current liabilities: | ||
Accrued dividends on convertible preferred stock | 2,387 | 1,963 |
Stockholders' deficit: | ||
Preferred stock |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Nov. 30, 2022 | May 31, 2022 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000 | 5,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 1,350,000 | 1,350,000 |
Common stock, shares issued | 825,279 | 720,028 |
Common stock, shares outstanding | 824,836 | 719,585 |
Treasury stock, shares | 443 | 443 |
Series B Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 400 | 400 |
Preferred stock, shares issued | 19 | 19 |
Preferred stock, shares outstanding | 19 | 19 |
Series C Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 8 | 8 |
Preferred stock, shares issued | 6 | 7 |
Preferred stock, shares outstanding | 6 | 7 |
Series D Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 12 | 12 |
Preferred stock, shares issued | 9 | 9 |
Preferred stock, shares outstanding | 9 | 9 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Nov. 30, 2022 | Nov. 30, 2021 | Nov. 30, 2022 | Nov. 30, 2021 | ||||
Consolidated Statements of Operations | |||||||
Revenue | [1] | $ 225 | $ 266 | ||||
Cost of goods sold | [1] | 52 | 53 | ||||
Gross profit | [1] | 173 | 213 | ||||
Operating expenses: | |||||||
General and administrative | $ 5,043 | 16,203 | [1] | $ 11,376 | 23,820 | [1] | |
Research and development | 137 | 7,447 | [1] | 713 | 19,467 | [1] | |
Amortization and depreciation | 54 | 252 | [1] | 153 | 528 | [1] | |
Inventory charge | 17,929 | 1,593 | [1] | 20,633 | 3,357 | [1] | |
Total operating expenses | 23,163 | 25,495 | [1] | 32,875 | 47,172 | [1] | |
Operating loss | (23,163) | (25,322) | [1] | (32,875) | (46,959) | [1] | |
Interest and other expenses: | |||||||
Interest on convertible notes | (1,159) | (1,426) | [1] | (2,305) | (3,112) | [1] | |
Amortization of discount on convertible notes | (580) | (793) | [1] | (1,156) | (1,745) | [1] | |
Amortization of debt issuance costs | (18) | (23) | [1] | (34) | (51) | [1] | |
Loss on induced conversion | (638) | (6,785) | [1] | (638) | (25,315) | [1] | |
Finance charges | (937) | (1,024) | [1] | (1,877) | (1,059) | [1] | |
Inducement interest expense | [1] | (4,704) | (5,232) | ||||
Legal settlement | [1] | (1,941) | |||||
Loss on derivatives | (8,601) | ||||||
Total interest and other expenses | (3,332) | (14,755) | [1] | (14,611) | (38,455) | [1] | |
Loss before income taxes | (26,495) | (40,077) | [1] | (47,486) | (85,414) | [1] | |
Income tax benefit | 0 | 0 | [1] | 0 | 0 | [1] | |
Net loss | $ (26,495) | $ (40,077) | [1],[2] | $ (47,486) | $ (85,414) | [1],[2] | |
Weighted average common shares outstanding, Basic | 813,373 | 662,600 | [1],[2] | 800,545 | 647,517 | [1],[2] | |
Weighted average common shares outstanding, Diluted | 813,373 | 662,600 | [2] | 800,545 | 647,517 | [2] | |
Loss per share, Basic | $ (0.03) | $ (0.06) | [1],[2] | $ (0.07) | $ (0.13) | [1],[2] | |
Loss per share, Diluted | $ (0.03) | $ (0.06) | [2] | $ (0.07) | $ (0.13) | [2] | |
[1] See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . See Note 2, Summary of Significant Accounting Policies |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders Deficit - USD ($) shares in Thousands, $ in Thousands | Preferred Stock Series B Convertible Preferred Stock | Preferred Stock Series C Convertible Preferred Stock | Preferred Stock | Common Stock Series B Convertible Preferred Stock | Common Stock Series C Convertible Preferred Stock | Common Stock Private Warrant Exchange [Member] | Common Stock Private Equity Offering | Common Stock | Treasury Stock | Additional Paid-in Capital Series C Convertible Preferred Stock | Additional Paid-in Capital Private Warrant Exchange [Member] | [1] | Additional Paid-in Capital Private Equity Offering | Additional Paid-in Capital | Accumulated Deficit | Series B Convertible Preferred Stock | [1] | Private Warrant Exchange [Member] | Private Equity Offering | Total | |||||||
Beginning balance at May. 31, 2021 | $ 626 | $ 532,031 | [1] | $ (553,675) | [1] | $ (21,018) | [1] | ||||||||||||||||||||
Beginning balance (shares) at May. 31, 2021 | 96 | 626,123 | 443 | ||||||||||||||||||||||||
Issuance of stock for convertible note repayment | $ 12 | 13,832 | [1] | 13,844 | [1] | ||||||||||||||||||||||
Issuance of stock for convertible note repayment (in shares) | 11,816 | ||||||||||||||||||||||||||
Loss on induced conversion | [1] | 18,530 | 18,530 | ||||||||||||||||||||||||
Issuance of legal settlement, warrants | [1] | 1,744 | 1,744 | ||||||||||||||||||||||||
Stock option exercises | [1] | 189 | 189 | ||||||||||||||||||||||||
Stock option exercises (in shares) | 300 | ||||||||||||||||||||||||||
Stock issued for compensation and tendered for income tax | $ 1 | (1) | [1] | ||||||||||||||||||||||||
Stock issued for compensation and tendered for income tax (in shares) | 1,014 | ||||||||||||||||||||||||||
Stock issued for private offerings | $ 3 | $ 2,869 | [1] | $ 2,872 | [1] | ||||||||||||||||||||||
Stock issued for private offerings (in shares) | 2,872 | ||||||||||||||||||||||||||
Warrant exercises | $ 1 | $ 1 | $ 774 | 502 | [1] | $ 775 | [1] | 503 | [1] | ||||||||||||||||||
Warrant exercises (in shares) | 1,327 | 668 | |||||||||||||||||||||||||
Inducement interest expense related to private warrant exchange | [1] | 528 | 528 | ||||||||||||||||||||||||
Dividends accrued on Series C and D convertible preferred stock | [1] | (420) | (420) | ||||||||||||||||||||||||
Stock-based compensation | [1] | 2,597 | 2,597 | ||||||||||||||||||||||||
Net loss | [1] | (45,337) | (45,337) | ||||||||||||||||||||||||
Ending balance at Aug. 31, 2021 | $ 644 | 573,595 | [1] | (599,432) | [1] | (25,193) | [1] | ||||||||||||||||||||
Ending balance (shares) at Aug. 31, 2021 | 96 | 644,120 | 443 | ||||||||||||||||||||||||
Beginning balance at May. 31, 2021 | $ 626 | 532,031 | [1] | (553,675) | [1] | (21,018) | [1] | ||||||||||||||||||||
Beginning balance (shares) at May. 31, 2021 | 96 | 626,123 | 443 | ||||||||||||||||||||||||
Loss on induced conversion | [1] | 25,315 | |||||||||||||||||||||||||
Net loss | [1],[2] | (85,414) | |||||||||||||||||||||||||
Ending balance at Nov. 30, 2021 | $ 686 | 626,558 | [1] | (639,940) | [1] | (12,696) | [1] | ||||||||||||||||||||
Ending balance (shares) at Nov. 30, 2021 | 36 | 685,861 | 443 | ||||||||||||||||||||||||
Beginning balance at May. 31, 2021 | $ 626 | 532,031 | [1] | (553,675) | [1] | (21,018) | [1] | ||||||||||||||||||||
Beginning balance (shares) at May. 31, 2021 | 96 | 626,123 | 443 | ||||||||||||||||||||||||
Ending balance at May. 31, 2022 | $ 720 | 671,013 | (766,131) | (94,398) | |||||||||||||||||||||||
Ending balance (shares) at May. 31, 2022 | 35 | 720,028 | 443 | ||||||||||||||||||||||||
Beginning balance at Aug. 31, 2021 | $ 644 | 573,595 | [1] | (599,432) | [1] | (25,193) | [1] | ||||||||||||||||||||
Beginning balance (shares) at Aug. 31, 2021 | 96 | 644,120 | 443 | ||||||||||||||||||||||||
Issuance of stock for convertible note repayment | $ 8 | 8,193 | [1] | 8,201 | [1] | ||||||||||||||||||||||
Issuance of stock for convertible note repayment (in shares) | 8,162 | ||||||||||||||||||||||||||
Loss on induced conversion | [1] | 6,785 | 6,785 | ||||||||||||||||||||||||
Stock option exercises | [1] | 200 | 200 | ||||||||||||||||||||||||
Stock option exercises (in shares) | 210 | ||||||||||||||||||||||||||
Stock issued for private offerings | $ 25 | 27,282 | [1] | 27,307 | [1] | ||||||||||||||||||||||
Stock issued for private offerings (in shares) | 25,178 | ||||||||||||||||||||||||||
Issuance costs related to stock issued for private offerings | [1] | (1,418) | (1,418) | ||||||||||||||||||||||||
Conversion of preferred stock to common stock | $ 1 | $ 1 | |||||||||||||||||||||||||
Conversion of preferred stock to common stock (in shares) | (60) | 600 | |||||||||||||||||||||||||
Warrant exercises | $ 7 | $ 1 | $ 4,608 | 532 | [1] | $ 4,615 | [1] | 533 | [1] | ||||||||||||||||||
Warrant exercises (in shares) | 6,593 | 963 | |||||||||||||||||||||||||
Inducement interest expense related to private warrant exchange | [1] | 4,704 | 4,704 | ||||||||||||||||||||||||
Dividends accrued on Series C and D convertible preferred stock | [1] | 17 | (431) | (414) | |||||||||||||||||||||||
Dividends accrued on Series C and D convertible preferred stock (in shares) | 35 | ||||||||||||||||||||||||||
Stock-based compensation | [1] | 2,060 | 2,060 | ||||||||||||||||||||||||
Net loss | [1] | (40,077) | (40,077) | [2] | |||||||||||||||||||||||
Ending balance at Nov. 30, 2021 | $ 686 | 626,558 | [1] | (639,940) | [1] | (12,696) | [1] | ||||||||||||||||||||
Ending balance (shares) at Nov. 30, 2021 | 36 | 685,861 | 443 | ||||||||||||||||||||||||
Beginning balance at May. 31, 2022 | $ 720 | 671,013 | (766,131) | (94,398) | |||||||||||||||||||||||
Beginning balance (shares) at May. 31, 2022 | 35 | 720,028 | 443 | ||||||||||||||||||||||||
Stock issued for compensation | $ 1 | 344 | $ 345 | ||||||||||||||||||||||||
Stock issued for compensation (in shares) | 879 | ||||||||||||||||||||||||||
Stock issued for private offerings | $ 85 | $ 17,459 | $ 17,544 | ||||||||||||||||||||||||
Stock issued for private offerings (in shares) | 85,378 | 4,600 | |||||||||||||||||||||||||
Issuance costs related to stock issued for private offerings | (6,289) | $ (6,289) | |||||||||||||||||||||||||
Conversion of preferred stock to common stock | $ 1 | $ (1) | |||||||||||||||||||||||||
Conversion of preferred stock to common stock (in shares) | (1) | 1,136 | |||||||||||||||||||||||||
Warrant exercises | $ 1 | 263 | 264 | ||||||||||||||||||||||||
Warrant exercises (in shares) | 657 | ||||||||||||||||||||||||||
Deemed dividend paid in common stock due to down round provision, recorded in additional paid-in capital | $ 5 | (5) | |||||||||||||||||||||||||
Deemed dividend paid in common stock due to down round provision recorded in additional paid-in capital (in share) | 4,620 | ||||||||||||||||||||||||||
Dividends accrued on Series C and D convertible preferred stock | (384) | (384) | |||||||||||||||||||||||||
Reclassification of warrants from liability to equity classified | 8,601 | 8,601 | |||||||||||||||||||||||||
Stock-based compensation | 996 | 996 | |||||||||||||||||||||||||
Reclassification of prior period preferred stock dividends | (4,265) | 4,265 | |||||||||||||||||||||||||
Net loss | (20,991) | (20,991) | |||||||||||||||||||||||||
Ending balance at Aug. 31, 2022 | $ 813 | 687,732 | (782,857) | (94,312) | |||||||||||||||||||||||
Ending balance (shares) at Aug. 31, 2022 | 34 | 812,698 | 443 | ||||||||||||||||||||||||
Beginning balance at May. 31, 2022 | $ 720 | 671,013 | (766,131) | (94,398) | |||||||||||||||||||||||
Beginning balance (shares) at May. 31, 2022 | 35 | 720,028 | 443 | ||||||||||||||||||||||||
Loss on induced conversion | $ 638 | ||||||||||||||||||||||||||
Warrant exercises (in shares) | 500 | ||||||||||||||||||||||||||
Net loss | $ (47,486) | ||||||||||||||||||||||||||
Ending balance at Nov. 30, 2022 | $ 825 | 692,558 | (809,352) | (115,969) | |||||||||||||||||||||||
Ending balance (shares) at Nov. 30, 2022 | 34 | 825,279 | 443 | ||||||||||||||||||||||||
Beginning balance at Aug. 31, 2022 | $ 813 | 687,732 | (782,857) | (94,312) | |||||||||||||||||||||||
Beginning balance (shares) at Aug. 31, 2022 | 34 | 812,698 | 443 | ||||||||||||||||||||||||
Issuance of stock for convertible note repayment | $ 2 | 498 | 500 | ||||||||||||||||||||||||
Issuance of stock for convertible note repayment (in shares) | 1,822 | ||||||||||||||||||||||||||
Loss on induced conversion | 638 | 638 | |||||||||||||||||||||||||
Stock issued for compensation | 310 | 310 | |||||||||||||||||||||||||
Stock issued for compensation (in shares) | 765 | ||||||||||||||||||||||||||
Exercise of warrants, net of offering costs | $ 10 | 2,123 | 2,133 | ||||||||||||||||||||||||
Exercise of warrants, net of offering costs (in shares) | 9,652 | 9,700 | |||||||||||||||||||||||||
Make-whole shares related to private warrant exchange (in shares) | 23 | ||||||||||||||||||||||||||
Dividend paid in common stock upon conversion of Series C convertible preferred stock ($0.50 per share) | 159 | 159 | |||||||||||||||||||||||||
Dividend paid in common stock upon conversion of Series C convertible preferred stock ($0.50 per share) (in shares) | 319 | ||||||||||||||||||||||||||
Dividends accrued on Series C and D convertible preferred stock | (369) | (369) | |||||||||||||||||||||||||
Stock-based compensation | 1,467 | 1,467 | |||||||||||||||||||||||||
Net loss | (26,495) | (26,495) | |||||||||||||||||||||||||
Ending balance at Nov. 30, 2022 | $ 825 | $ 692,558 | $ (809,352) | $ (115,969) | |||||||||||||||||||||||
Ending balance (shares) at Nov. 30, 2022 | 34 | 825,279 | 443 | ||||||||||||||||||||||||
[1] See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . See Note 2, Summary of Significant Accounting Policies |
Consolidated Statement of Cha_2
Consolidated Statement of Changes in Stockholders Deficit (Parenthetical) | 3 Months Ended |
Nov. 30, 2022 $ / shares | |
Consolidated Statement of Changes in Stockholders' Deficit | |
Dividends declared and paid, per share | $ 0.50 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Nov. 30, 2022 | Nov. 30, 2021 | [2] | Nov. 30, 2022 | Nov. 30, 2021 | |||
Cash flows from operating activities: | |||||||
Net loss | $ (26,495) | $ (40,077) | [1] | $ (47,486) | $ (85,414) | [1],[2] | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Amortization and depreciation | 54 | 252 | 153 | 528 | [2] | ||
Amortization of debt issuance costs | 18 | 23 | 34 | 51 | [2] | ||
Amortization of discount on convertible notes | 580 | 793 | 1,156 | 1,745 | [2] | ||
Warrants issued for legal settlement | [2] | 1,744 | |||||
Loss on derivatives | 8,601 | ||||||
Loss on induced conversion | 638 | 6,785 | 638 | 25,315 | [2] | ||
Inducement interest expense and non-cash finance charges | [2] | 5,232 | |||||
Inventory charge | 17,929 | 1,593 | 20,633 | 3,357 | [2] | ||
Stock-based compensation | 3,118 | 4,657 | [2] | ||||
Changes in operating assets and liabilities: | |||||||
Increase in prepaid expenses and other assets | (303) | (654) | [2] | ||||
Decrease in accounts payable and accrued expenses | (2,024) | (17,193) | [2] | ||||
Net cash used in operating activities | (15,480) | (60,632) | [2] | ||||
Cash flows from investing activities: | |||||||
Furniture and equipment purchases | [2] | (13) | |||||
Net cash used in investing activities | [2] | (13) | |||||
Cash flows from financing activities: | |||||||
Proceeds from warrant transactions, net of offering costs | 2,133 | 5,390 | [2] | ||||
Proceeds from sale of common stock and warrants, net of issuance costs | 11,255 | 28,761 | [2] | ||||
Proceeds from warrant exercises | 264 | 1,036 | [2] | ||||
Proceeds held in trust | 200 | ||||||
Proceeds from stock option exercises | [2] | 390 | |||||
Net cash provided by financing activities | 13,852 | 35,577 | [2] | ||||
Net change in cash and restricted cash | (1,628) | (25,068) | [2] | ||||
Cash beginning of period | 4,231 | 33,943 | [2] | ||||
Cash end of period | 2,603 | 8,875 | 2,603 | 8,875 | [2] | ||
Cash and restricted cash consisted of the following: | |||||||
Cash | 2,403 | 8,875 | 2,403 | 8,875 | [2] | ||
Restricted cash | 200 | 200 | |||||
Total cash and restricted cash | 2,603 | $ 8,875 | 2,603 | 8,875 | [2] | ||
Supplemental disclosure: | |||||||
Cash paid for interest | [2] | 57 | |||||
Non-cash investing and financing transactions: | |||||||
Derivative liability associated with warrants | 8,601 | ||||||
Issuance of common stock for principal and interest of convertible notes | 500 | 22,045 | [2] | ||||
Accrued dividends on Series C and D convertible preferred stock | 753 | 834 | [2] | ||||
Dividend paid in common stock on Series B and C convertible preferred stock conversions | 159 | $ 17 | [2] | ||||
Deemed dividend due to equity modifications, recorded in additional paid-in capital | $ 5,294 | $ 5,294 | |||||
[1] See Note 2, Summary of Significant Accounting Policies See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |
Organization
Organization | 6 Months Ended |
Nov. 30, 2022 | |
Organization | |
Organization | Note 1. Organization CytoDyn Inc. (together with its wholly owned subsidiaries, the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002, under the name RexRay Corporation and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company focused on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab (PRO 140), a novel humanized monoclonal antibody targeting the CCR5 receptor. The Company has been engaged in studying leronlimab for use in the treatment of human immunodeficiency virus (“HIV”), non-alcoholic steatohepatitis (“NASH”), and solid tumors in oncology. The Company has been investigating leronlimab as a viral entry inhibitor for HIV, believed to competitively bind to the N-terminus and second extracellular loop of the CCR5 receptor. For immunology, the CCR5 receptor is believed to be implicated in immune-mediated illnesses such as NASH. The CCR5 receptor may also be present on cells that undergo malignant transformation and may also be present in the tumor microenvironment. Leronlimab is being studied in NASH, NASH-HIV, solid tumors in oncology, and other HIV indications where CCR5 is believed to play an integral role. The Company is pursuing the regulatory approval of leronlimab in hopes that commercial sales will be obtained for one or more indications. The Company previously submitted a Biologic License Application (“BLA”) for leronlimab as a combination therapy with highly active antiretroviral therapy (“HAART”) for highly treatment-experienced HIV patients. In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA submission. The FDA informed the Company that the BLA did not contain certain information and data needed to complete a substantive review and therefore, the FDA would not file the BLA. In November 2021, the Company resubmitted the non-clinical and chemistry, manufacturing, and controls (“CMC”) sections of the BLA. As previously reported and as described in Note 9, Commitments and Contingencies - Legal Proceedings Additionally, in March 2022, the FDA placed the Company’s HIV trials on a partial clinical hold. In October 2022, the Company voluntarily withdrew its BLA submission after concluding that a significant risk existed that the BLA would not receive FDA approval due to the CRO's inadequate process and performance around the monitoring and oversight of the clinical data. The Company’s efforts are currently directed toward obtaining removal of the clinical hold. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Nov. 30, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited interim consolidated financial statements include the accounts of CytoDyn Inc. and its wholly owned subsidiaries, CytoDyn Operations Inc. and Advanced Genetic Technologies, Inc. (“AGTI”); AGTI is a dormant entity. The consolidated financial statements reflect all normal recurring adjustments which are, in the opinion of management, necessary for a fair statement of the results of operations for the interim financial statements. The interim financial information and notes thereto should be read in conjunction with the Company's latest Annual Report on Form 10-K for the fiscal year ended May 31, 2022 (the “2022 Form 10-K”) The results of operations for the periods presented are not necessarily indicative of results to be expected for the entire fiscal year or for any other future annual or interim period. Reclassifications Certain prior year and prior quarter amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the current period presentation. Such reclassifications did not have material effect on the Company’s previously reported financial position, results of operations, stockholders’ deficit, or net cash provided by operating activities. During the quarter ended August 31, 2022, the Company reclassified amounts recorded as accumulated dividends for Series C and D preferred stockholders from accumulated deficit to additional paid-in capital. These reclassifications were made to reflect the proper presentation for accrued dividends when an entity has accumulated deficit. Revision and Restatement of Financial Statements During the preparation of the quarterly financial statements as of and for the period ended November 30, 2021, the Company identified an error in how non-cash inducement interest expense was calculated in previous reporting periods dating back to fiscal year 2018. The error resulted in an understatement of non-cash inducement interest expense and additional paid-in capital. For details, refer to Note 2, Summary of Significant Accounting Policies - Revision of Financial Statements in the 2022 Form 10-K. Also, during the preparation and audit of the annual financial statements as of and for the fiscal year ended May 31, 2022, the Company concluded that a material error was identified in how the Company was accounting for common stock issued to settle certain convertible note obligations dating back to fiscal year 2021. For details, refer to Note 14, Restatement in the 2022 Form 10-K. Neither of the errors had impact on operating loss, cash, net cash used in or provided by operating, financing, and investing activities, assets, liabilities, commitments and contingencies, total stockholders’ deficit, number of shares issued and outstanding, basic and diluted weighted average common shares outstanding, and number of shares available for future issuance for any period presented, and are reflected in the accompanying statement of operations, changes in stockholders’ deficit, and statement of cash flows. Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As presented in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of approximately $47.5 million for the six months ended November 30, 2022 and has an accumulated deficit of approximately $809.4 million as of November 30, 2022. These factors, among several others, including the various legal matters discussed in Note 9, Commitments and Contingencies – Legal Proceedings The Company’s continuance as a going concern is dependent upon its ability to obtain additional operating capital, complete the development of its product candidate, leronlimab, obtain approval to commercialize leronlimab from regulatory agencies, continue to outsource manufacturing of leronlimab, and ultimately achieve revenues and attain profitability. The Company plans to continue to engage in research and development activities related to leronlimab for multiple indications and expects to incur significant research and development expenses in the future, primarily related to its regulatory compliance, including seeking the lifting of the FDA’s clinical hold with regard to the Company’s HIV program, performing additional clinical trials, and seeking regulatory approval for its product candidate for commercialization. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs primarily from the sale of equity and debt securities, combined with additional funding from other sources. However, there can be no assurance that the Company will be successful in these endeavors. Use of Estimates The preparation of the consolidated financial statements in accordance with accounting principles generally accepted in the United States (U.S. GAAP) requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Estimates are assessed each period and updated to reflect current information, such as the status of our analysis of the results of our clinical trials and/or discussions with the FDA which could have an impact on the Company’s significant accounting estimates and assumptions. The Company’s estimates are based on historical experience and on various market and other relevant, appropriate assumptions. Significant estimates include, but are not limited to, those relating to capitalization of pre-launch inventories, charges for excess and obsolete inventories, research and development expenses, commitments and contingencies, stock-based compensation, and the assumptions used to value warrants and warrant modifications. Actual results could differ from these estimates. Pre-launch Inventories Pre-launch inventories were comprised of raw materials required to commercially produce leronlimab and substantially completed commercially produced leronlimab in anticipation of commercial sales of the product upon potential regulatory approval as a combination therapy for HIV patients in the United States. The Company’s pre-launch inventories consisted of (1) raw materials purchased for commercial production, (2) work-in-progress materials which consisted of bulk drug substance, which was the manufactured drug stored in bulk storage, and (3) drug product, which was the manufactured drug in unlabeled vials. The consumption of raw materials during production was classified as work-in-progress until saleable. Once it is determined to be in saleable condition, following regulatory approval, inventory is classified as finished goods. The Company capitalizes inventories procured or produced in preparation for product launches. Typically, capitalization of such inventory begins when the results of clinical trials have reached a status sufficient to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced, and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The material factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and status of the Company’s regulatory applications. The Company closely monitors the status of the product within the regulatory review and approval process, including all relevant communications with regulatory authorities. If the Company becomes aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, it may make a determination that the related inventory no longer qualifies for capitalization. The Company determines whether raw materials purchased for commercial production are usable for production based on the manufacturer’s assigned expiration date. In evaluating whether raw materials included in the pre-launch inventories will be usable for production, the Company takes into account the shelf-life of raw materials at the time they are expected to be used in manufacturing. Any raw materials past expiration date at the time of the next manufacturing run are removed from inventory. As one stage of the manufacturing process, the Company produces work-in-progress materials which consist of bulk drug substance, which is the manufactured drug stored in bulk storage. The initial shelf-life of bulk drug substance is established based on prior experience and periodically performed stability studies and is set at four years from the date of manufacturing. Bulk drug substance is subject to deep freeze storage, and stability studies are performed on a periodic basis in accordance with the established stability protocols. If drug substance meets suitability criteria beyond the initial shelf-life, its shelf-life may be extended based on prior experience and stability trend analysis, and during the extension period periodic stability testing is performed on the drug substance. Regardless of the number of stability studies performed, if drug substance continues to meet prespecified suitability parameters it may be used in manufacturing; if drug substance fails to meet suitability criteria beyond its assigned shelf-life at that time, it may no longer be used and is considered to be expired. The Company utilizes resins, a reusable raw material, in its bulk drug manufacturing process. Shelf-life of a resin used in commercial manufacturing of biologics is determined by the number of cycles for which it has been validated to be used in a manufacturing process before it is considered unusable. Unpacked and unused resins have a manufacturer’s expiration date by which resins are expected to start being used in the manufacturing process without loss of their properties. Prior to a new manufacturing campaign, and between manufacturing campaigns, the resins are removed from storage, and are treated and tested for suitability. Once resins are used in the manufacturing process, their shelf-life is measured by a validated predetermined number of manufacturing cycles they are usable for, conditional on appropriate storage solution under controlled environment between production campaigns, as well as by performing pre-production usability testing. Before a manufacturing campaign, each resin is tested for suitability. Regardless of the number of cycles, if a resin fails to meet prespecified suitability parameters it may not be used in manufacturing; likewise, even if the resin meets suitability criteria beyond the lifetime cycles, it may no longer be used. The cost of the resins used in a manufacturing campaign is allocated to the cost of the drug product in vials. The Company values its inventory at the lower of cost or net realizable value using the average cost method. Inventory is evaluated for recoverability by considering the likelihood that revenue will be obtained from the future sale of the related inventory considering the status of the product within the regulatory approval process. The Company evaluates its inventory levels on a quarterly basis and writes down inventory that became obsolete, has a cost in excess of its expected net realizable value, or is in quantities in excess of expected requirements. In assessing the lower of cost or net realizable value for pre-launch inventory, the Company relies on independent analyses provided by third parties knowledgeable about the range of likely commercial prices comparable to current comparable commercial product. Quarterly, the Company also evaluates whether certain raw materials held in its inventory are expected to reach the end of their estimated shelf-lives based on passage of time, the number of manufacturing cycles they are used in and results of pre-production testing prior to the expected production date, or when resins used in the manufacturing process fail suitability tests. If any of such events occur, the Company may make a determination to record a charge if it is expected that such inventories will become obsolete prior to the expected production date. Anticipated future sales, shelf lives, and expected approval date are considered when evaluating realizability of capitalized inventory. The shelf-life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventories, the Company considers the product stability data for all of the pre-approval inventory procured or produced to date to determine whether there is adequate shelf-life. When the remaining shelf-life of drug product inventory is less than 12 months, it is likely that it will not be accepted by potential customers. However, as inventories approach their shelf-life expiration, the Company may perform additional stability testing to determine if the inventory is still viable, which can result in an extension of its shelf-life and revaluation of the need for and the amount of the previously recorded reserves. Further, in addition to performing additional stability testing, certain raw materials inventory may be sold in its then current condition prior to reaching expiration. If the Company determines that it is not likely that shelf-life may be extended or the inventory cannot be sold prior to expiration, the Company may record a charge to bring inventory to its net realizable value. In October 2022, the Company voluntarily withdrew its BLA submission after concluding that a significant risk existed that the BLA would not receive FDA approval due to the inadequate process and performance by its former CRO around the monitoring and oversight of the clinical data from its trials. Following this decision, none of the Company’s inventories now qualify for capitalization as pre-launch inventories. See Note 3, Inventories, net For additional information about the Company’s significant accounting policies, refer to Note 2, Summary of Significant Accounting Policies, Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) retrospective method of transition is permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASU No. 2020-06 as of June 1, 2022, using the modified retrospective method. The adoption of ASU No. 2020-06 had no impact on the Company’s balance sheets, statements of operations, cash flows or financials statement disclosures. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options The Company adopted the new guidance prospectively as of June 1, 2022 and used the framework to record a modification to equity classified warrants during the six months ended November 30, 2022. The modification to equity instruments, consisting of a trigger of a down round provision was recorded as a deemed dividend in accordance with this guidance, resulting in an approximate $4.2 million charge to additional paid-in capital, induced warrant exercises recorded as $2.1 million issuance cost and $0.5 million deemed dividend, and the extension of warrant expiration dates recorded as a $0.5 million deemed dividend. The deemed dividends were included in the loss per share calculation; refer to Note 7 , Loss per Common Share , Equity Awards and Warrants |
Inventories, net
Inventories, net | 6 Months Ended |
Nov. 30, 2022 | |
Inventories, net | |
Inventories, net | Note 3. Inventories, net Inventories were as follows (in thousands): November 30, 2022 May 31, 2022 Raw materials $ — $ 16,264 Work-in-progress — 1,665 Total inventories, net $ — $ 17,929 The table below summarizes pre-launch inventories that had been capitalized and charged-off for GAAP accounting purposes due to no longer qualifying for inventory capitalization as pre-launch inventories due to the withdrawal of the BLA submission and estimated expiration based on remaining shelf life. Work-in-progress and finished drug product inventories continue to be physically maintained, can be used for clinical trials, and can be commercially sold upon regulatory approval if the shelf-lives can be extended as a result of the performance of on-going stability tests. Raw material continues to be maintained so that they can be used in the future if needed. Raw Materials Work-in-progress (in thousands, Expiration period ending November 30,) Remaining shelf-life (mos) Specialized Resins Other Total Raw Materials Bulk drug product Finished drug product Total inventories 2023 0 to 12 $ 4,764 $ 16,264 $ - $ 21,028 $ - $ - $ 21,028 2024 13 to 24 2,511 - 1,590 4,101 1,661 29,142 34,904 2025 25 to 36 189 - - 189 - 32,343 32,532 2026 37 to 48 2,115 - - 2,115 - - 2,115 Thereafter 49 or more - - - - - - - Inventories, gross 9,579 16,264 1,590 27,433 1,661 61,485 90,579 Inventory charge (9,579) (16,264) (1,590) (27,433) (1,661) (61,485) (90,579) Inventories, net $ - $ - $ - $ - $ - $ - $ - During the first quarter of fiscal year 2023, the Company reviewed purchase commitments made by its manufacturing partner, Samsung BioLogics Co., Ltd. (“Samsung”), under the master agreement between the Company and Samsung, and its vendors for specialized raw materials for which the Company made a prepayment in the amount of $2.7 million in the third quarter of fiscal year 2022, which were recorded as prepaid expenses in the consolidated financial statements as of May 31, 2022. As discussed in Note 9, Commitments and Contingencies – Commitments with Samsung BioLogics Co., Ltd. (“Samsung”) , t In October 2022, the Company voluntarily withdrew its rolling BLA submission after concluding that a significant risk existed that the BLA would not receive FDA approval due to the inadequate process and performance by its former CRO around the monitoring and oversight of the clinical data from its trials. Following this decision, none of the Company’s inventories now qualify for capitalization as pre-launch inventories. For the three months ended November 30, 2022, the Company charged-off the remaining raw material resin and work-in-progress bulk product inventories of approximately For additional information, refer to Note 2, Summary of Significant Accounting Policies – Pre-launch Inventories Inventories, net |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 6 Months Ended |
Nov. 30, 2022 | |
Accounts Payable and Accrued Liabilities | |
Accounts Payable and Accrued Liabilities | Note 4. Accounts Payable and Accrued Liabilities As of November 30, 2022 and May 31, 2022, the accounts payable balance was approximately $67.2 million and $68.0 million, respectively, with two vendors accounting for 70% and 73% of the total balance of accounts payable at the respective dates. The components of accrued liabilities are as follows (in thousands): November 30, 2022 May 31, 2022 Compensation and related expense $ 496 $ 1,522 Legal fees and settlement 166 2,006 Clinical expense 1,176 3,727 Accrued inventory charges and expenses 3,155 1,392 License fees 393 150 Lease payable 136 134 Other liabilities 200 64 Total accrued liabilities $ 5,722 $ 8,995 |
Convertible Instruments and Acc
Convertible Instruments and Accrued Interest | 6 Months Ended |
Nov. 30, 2022 | |
Convertible Instruments and Accrued Interest | |
Convertible Instruments and Accrued Interest | Note 5. Convertible Instruments and Accrued Interest Convertible Preferred Stock The following table presents the number of potentially issuable shares of common stock should shares of preferred stock and amounts of undeclared and accrued preferred dividends be converted to common stock. November 30, 2022 May 31, 2022 (in thousands) Series B Series C Series D Series B Series C Series D Shares of preferred stock 19 6 9 19 7 9 Total shares of common stock if converted 190 12,670 10,565 190 13,806 10,565 Undeclared dividends $ 12 $ - $ - $ 10 $ - $ - Accrued dividends $ - $ 2,184 $ 2,387 $ - $ 2,014 $ 1,963 Total shares of common stock if dividends converted 25 4,368 4,774 20 4,028 3,926 Under the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), dividends on its outstanding shares of Series B Convertible Preferred Stock (the “Series B preferred stock”) may be paid in cash or shares of the Company’s common stock at the option of the Company. Dividends on outstanding shares of Series C Convertible Preferred Stock (the “Series C preferred stock”) and Series D Convertible Preferred Stock (the “Series D preferred stock”) are payable in cash or shares of common stock at the election of the holder. The preferred stockholders have the right to dividends only when and if declared by the Company’s Board of Directors. Under Section 170 of the Delaware General Corporation Law, the Company is permitted to pay dividends only out of capital surplus or, if none, out of net profits for the fiscal year in which the dividend is declared or net profits from the preceding fiscal year. Series B Convertible Preferred Stock Each share of the Series B preferred stock is convertible into ten shares of the Company’s common stock. Dividends are cumulative and payable to the Series B preferred stockholders when and as declared by the Company’s Board of Directors (the “Board”). Dividends on the Series B preferred stock accumulate at the rate of $0.25 per share per annum, and may be paid, at the option of the Company at the time of conversion, either in cash or shares of the Company’s common stock valued at $0.50 per share. The Series B preferred stock has liquidation preferences over the common shares at $5.00 per share, plus any accrued and unpaid dividends. Except as provided by law, the Series B preferred stockholders have no voting rights. The Company does not accrue dividends on Series B preferred stock until such dividends are declared. Series C and Series D Convertible Preferred Stock The Series C and Series D Certificates of Designation provide, among other things, that holders of Series C and Series D preferred stock shall be entitled to receive, when and as declared by the Board and out of any assets at the time legally available therefor, cumulative dividends at the rate of ten percent (10%) per share per annum of the stated value of the Series C and Series D preferred stock, which is $1,000 per share (the “Stated Value”). Dividends on the Series C and Series D preferred stock are cumulative, and will accrue and be compounded annually, whether or not declared and whether or not there are any profits, surplus or other funds or assets of the Company legally available therefor. Dividends on the Series C and Series D preferred stock may be paid in cash or shares of the Company’s common stock at the option of the holder. Series C and Series D preferred stock does not have redemption rights. Each share of Series C and Series D preferred stock is convertible at the holder’s option into shares of common stock, with Series C stockholders having conversion price of $0.50 per share, and Series D stockholders having conversion price of $0.80 per share, together with accrued and unpaid dividends payable, at the option of the holder, in cash or shares of common stock based on the conversion price. Given the obligation to settle all dividends, including those in arrears, in cash at the election of the preferred stockholder upon conversion, whether or not declared by the Company, the Company accrues dividends on Series C and D preferred stock as a liability in its consolidated financial statements. In the event of liquidation, dissolution or winding up of the Company, the holders of Series D preferred stock will be entitled to receive, on a pari passu basis with the holders of the Series C preferred stock and in preference to any payment or distribution to holders of the Series B preferred stock and common stock, an amount per share equal to the Stated Value plus the amount of any accrued and unpaid dividends. If, at any time while the Series C and Series D preferred stock is outstanding, the Company effects any reorganization, merger or consolidation of the Company, sale of substantially all of its assets, or other specified transaction (each, as defined in the Series C and the Series D Certificates of Designation, a “Fundamental Transaction”), a holder of Series C and Series D preferred stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series C and Series D preferred stock immediately prior to the Fundamental Transaction. Except as otherwise provided in the Series C and Series D Certificates of Designation or as otherwise required by law, the Series C and Series D preferred stock have no voting rights. Convertible Notes and Accrued Interest November 30, 2022 May 31, 2022 (in thousands) April 2, 2021 Note April 23, 2021 Note Total April 2, 2021 Note April 23, 2021 Note Total Convertible notes payable outstanding principal $ 9,319 $ 28,500 $ 37,819 $ 9,819 $ 28,500 $ 38,319 Less: Unamortized debt discount and issuance costs (198) (690) (888) (512) (1,566) (2,078) Convertible notes payable, net 9,121 27,810 36,931 9,307 26,934 36,241 Accrued interest on convertible notes 3,242 5,037 8,279 2,599 3,375 5,974 Outstanding convertible notes payable, net and accrued interest $ 12,363 $ 32,847 $ 45,210 $ 11,906 $ 30,309 $ 42,215 Reconciliation of changes to the outstanding balance of convertible notes, including accrued interest, were as follows: (in thousands) April 2, 2021 Note April 23, 2021 Note Total Outstanding balance at May 31, 2022 $ 11,906 $ 30,309 $ 42,215 Amortization of issuance discount and costs 314 876 1,190 Interest expense 643 1,662 2,305 Fair market value of shares exchanged for repayment (638) - (638) Difference between market value of 138 - 138 Outstanding balance at November 30, 2022 $ 12,363 $ 32,847 $ 45,210 Long-term Convertible Note – April 2, 2021 Note On April 2, 2021, the Company entered into a securities purchase agreement pursuant to which the Company issued a secured convertible promissory note with a two-year term in the initial principal amount of $28.5 million (the “April 2, 2021 Note”). The Company received consideration of $25.0 million, reflecting an original issue discount of $3.4 million and issuance costs of $0.1 million. Interest accrues at an annual rate of 10% on the outstanding balance, with the rate increasing to the lesser of 22% per annum or the maximum rate permitted by applicable law upon occurrence of an event of default. In addition, upon any event of default, the investor may accelerate the outstanding balance payable under the April 2, 2021 Note; upon such acceleration, the outstanding balance will increase automatically by 15%, 10% or 5%, depending on the nature of the event of default. The events of default are listed in Section 4 of the April 2, 2021 Note filed as Exhibit 4.1 Pursuant to the terms of the April 2, 2021 Note, the Company must obtain the investor’s consent before assuming additional debt with aggregate net proceeds to the Company of less than $50.0 million. In the event of any such approval, the outstanding principal balance of the April 2, 2021 Note will increase automatically by 5% upon the issuance of such additional debt The investor may convert all or any part the outstanding balance of the April 2, 2021 note into shares of common stock at an initial conversion price of $10.00 per share upon five trading days’ notice, subject to certain adjustments and volume and ownership limitations. In addition to standard anti-dilution adjustments, the conversion price of the April 2, 2021 Note is subject to full-ratchet anti-dilution protection, pursuant to which the conversion price will be automatically reduced to equal the effective price per share in any new offering by the Company of equity securities that have registration rights, are registered or become registered under the Securities Act of 1933, as amended (the “Securities Act”). The April 2, 2021 Note provides for liquidated damages upon failure to deliver common stock within specified timeframes and requires the Company to maintain a share reservation of 6.0 million shares of common stock. The investor may redeem any portion of the note, at any time beginning six months after the issue date upon three trading days’ notice, subject to a maximum monthly redemption amount of $3.5 million. The April 2, 2021 Note requires the Company to satisfy its redemption obligations in cash within three trading days of the Company’s receipt of such notice. The Company may prepay the outstanding balance of the note, in part or in full, plus a 15% premium, at any time upon 15 trading days’ notice. Pursuant to the terms of the April 2, 2021 Note, the Company is obligated, at the discretion of the noteholder, to reduce the outstanding balance by $7.5 million per month for five months. During fiscal year 2022, in partial satisfaction of debt reduction amounts, the Company and the April 2, 2021 Note holder entered into exchange agreements, pursuant to which the April 2, 2021 Note was partitioned into new notes (the “Partitioned Notes”) with an aggregate principal amount of $18.7 million, which were exchanged concurrently with the issuance of approximately 25.3 million shares of common stock. The outstanding balance of the April 2, 2021 Note was reduced by the Partitioned Notes to a principal amount of $9.8 million. The Company accounted for the restructured partitioned notes and exchange settlements as induced conversion, and, accordingly, recorded an aggregate loss on convertible debt induced conversion of $18.8 million through May 31, 2022. During the three months ended November 30, 2022, in satisfaction of a redemption, the Company and the April 2, 2021 Note holder entered into an exchange agreement, pursuant to which the April 2, 2021 Note was partitioned into a new note (the “November Partitioned Note”) with a principal amount of $0.5 million, which was exchanged concurrently with the issuance of approximately 1.8 million shares of common stock. The outstanding balance of the April 2, 2021 Note was reduced by the November Partitioned Note to a principal amount of $9.3 million. The Company accounted for the November Partitioned Note and exchange settlement as an induced conversion, and, accordingly, recorded a non-cash loss on convertible debt induced conversion of $0.6 million for the three months ended November 30, 2022. For the six months ended November 30, 2022 and 2021, the Company recorded $0.6 million and $6.8 million, respectively, in loss on convertible debt induced conversion. Long-term Convertible Note – April 23, 2021 Note On April 23, 2021, the Company entered into a securities purchase agreement pursuant to which the Company issued a secured convertible promissory note with a two-year term to an institutional accredited investor affiliated with the holder of the April 2, 2021 Note in the initial principal amount of $28.5 million (the “April 23, 2021 Note”). The Company received consideration of $25.0 million, reflecting an original issue discount of $3.4 million and issuance costs of $0.1 million. Interest accrues at an annual rate of 10% on the outstanding balance of the April 23, 2021 Note, with the rate increasing to the lesser of 22% per annum or the maximum rate permitted by applicable law upon the occurrence of an event of default. In addition, upon any event of default, the investor may accelerate the outstanding balance payable under the April 23, 2021 Note; upon such acceleration, the outstanding balance will increase automatically by 15%, 10% or 5%, depending on the nature of the event of default. The events of default are listed in Section 4 of the April 23, 2021 Note filed as Exhibit 4.1 Pursuant to the terms of the April 23, 2021 Note, the Company must obtain the investor’s consent before assuming additional debt with aggregate net proceeds to the Company of less than $75.0 million. In the event of any such approval, the outstanding principal balance of the April 23, 2021 Note will increase automatically by 5% upon the issuance of such additional debt. The investor may convert all or any part of the outstanding balance into shares of common stock at an initial conversion price of $10.00 per share upon five three three The holders of the April 2 and April 23 Notes waived provisions in the notes that could have triggered the imposition of a default interest rate, a downward adjustment of the conversion price, or specified other provisions relating to default, breach or imposition of a penalty. The related events included the grant of registration rights to investors in specified private offerings, the issuance of warrants to purchase up to 45 million shares of common stock with registration rights to certain parties and potential incurrence of debt pursuant to a Surety Bond Backstop Agreement, and the grant of a security interest in the Company’s intellectual property to certain parties to the Surety Bond Backstop Agreement. Refer to Note 6, Equity Awards and Warrants |
Equity Awards and Warrants
Equity Awards and Warrants | 6 Months Ended |
Nov. 30, 2022 | |
Equity Awards and Warrants | |
Equity Awards | Note 6. Equity Awards and Warrants Approval of Increase in Authorized Common Stock On August 31, 2022, at a special stockholders’ meeting, the Company’s stockholders approved a proposal to increase the total number of authorized shares of common stock from 1.0 billion shares to 1.35 billion shares. Liability Classified Warrants From June 24, 2022 through August 31, 2022, the Company had insufficient authorized common stock to reserve for the shares underlying the Surety Backstop warrants and warrants issued to a placement agent in connection with the June 2022 offering (Refer to Private Placement of Warrants under Surety Bond Backstop Agreement Private Placement of Common Stock and Warrants through Placement Agent Derivatives and Hedging. In accordance with the prescribed accounting guidance, the Company measured fair value of liability classified warrants using fair value hierarchy which include: Level 1. Level 2. Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. Level 2 inputs also include non-binding market consensus prices that can be corroborated with observable market data, as well as quoted prices that were adjusted for security-specific restrictions. Level 3. Unobservable inputs to the valuation methodology are significant to the measurement of the fair value of assets or liabilities. These Level 3 inputs also include non-binding market consensus prices or non-binding broker quotes that the Company was unable to corroborate with observable market data. As of August 31, 2022, in accordance with ASC 815, Derivatives and Hedging, (in thousands) Liability Classified Warrants Balance at May 31, 2022 $ — Classified as liability due to lack of shares availability at issuance 14,522 Classified as equity upon increase in availability (23,123) Loss on derivative due to change in fair market value 8,601 Balance at August 31, 2022 $ — The Company used a Black Scholes valuation model to estimate the value of the liability classified warrants using assumptions presented in the table below. The Black Scholes valuation model was used because management believes it reflects all the assumptions that market participants would likely consider in negotiating the transfer of the warrant. The Company’s derivative liability is classified within Level 3. Initial Fair Market Value At Issuance Fair Market Value at August 31, 2022 Backstop Backstop Placement Backstop Backstop Placement Warrant #1 Warrant #2 Agent Warrants Warrant #1 Warrant #2 Agent Warrants Fair value of underlying stock $ 0.44 $ 0.42 $ 0.44 $ 0.52 $ 0.52 $ 0.52 Risk free rate 3.17% 3.06% 3.13% 3.34% 3.31% 3.16% Expected term (in years) 4.65 5.00 10.00 4.46 4.88 9.82 Stock price volatility 110.20% 109.49% 95.99% 117.29% 113.59% 95.87% Expected dividend yield 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% The Company had no liability classified warrants as of or during the quarter ended November 30, 2022. Equity Incentive Plan (“EIP”) As of November 30, 2022, the Company had one active stock-based equity plan, the CytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan The Company recognizes the compensation cost of employee and director services received in exchange for awards of equity instruments based on the grant date estimated fair value of the awards. The Company estimates the fair value of RSUs and PSUs using the value of the Company’s stock on the date of grant. Share-based compensation cost is recognized over the period during which the employee or director is required to provide service in exchange for the award and, as forfeitures occur, the associated compensation cost recognized to date is reversed. For awards with performance-based payout conditions, the Company recognizes compensation cost based on the probability of achieving the performance conditions, with changes in expectations recognized as an adjustment to earnings in the period of change. Any recognized compensation cost is reversed if the conditions are ultimately not met. Stock-based compensation for the three months ended November 30, 2022 and 2021 was $1.8 million and $2.1 million, respectively, and for the six months ended November 30, 2022 and 2021 was $3.1 million and $4.7 million, respectively. Stock-based compensation is recorded as part of general and administrative costs. Stock Options and Warrants Stock option and warrant activity is presented in the table below: Weighted average Weighted remaining Aggregate Number of average contractual intrinsic (in thousands, except per share data) shares exercise price life in years value Options and warrants outstanding at May 31, 2022 90,705 $ 0.77 4.06 $ 352 Granted 116,439 $ 0.29 Exercised (2,097) $ 0.79 Forfeited, expired, and cancelled (2,147) $ 1.49 Options and warrants outstanding at November 30, 2022 202,900 $ 0.48 4.80 $ 9,616 Options and warrants outstanding and exercisable at November 30, 2022 189,085 $ 0.47 4.48 $ 9,540 During the six months ended November 30, 2022 and 2021, stock options for 12.4 million shares and 11.0 million shares, respectively, were granted. Of the current year options, 10.9 million options vest over four years, 1.1 million vest over one year, and 0.4 million vested immediately. Prior year options granted vest over three years. The Company records compensation expense based on the Black-Scholes fair value per share of the awards on the grant date. The weighted average fair value per share was $0.34 and $1.11 for the six months ended November 30, 2022 and 2021, respectively. Restricted Stock Units (“RSUs”) and Performance Stock Units (“PSUs”) The Company’s stock incentive plan provides for equity instruments, such as RSUs and PSUs, which grant the right to receive a specified number of shares over a specified period of time. RSUs and PSUs are service-based awards that vest according to the terms of the grant. PSUs have performance-based payout conditions. The following table summarizes the Company’s RSU and PSU activity: Number of Weighted-average (in thousands, except per share data) RSUs and PSUs (1) grant date fair value Unvested RSUs and PSUs at May 31, 2022 300 $ 3.12 RSUs and PSUs granted 1,293 0.58 Unvested RSUs and PSUSs forfeited (67) 3.12 RSUs and PSUs vested (150) 3.12 Unvested RSUs and PSUs at November 30, 2022 1,376 $ 0.73 ( 1 The number of PSUs disclosed in this table are at the target level of 100%. The unvested balance of RSUs and PSUs as of November 30, 2022 includes approximately 0.6 million PSUs. The vesting of these awards is subject to the achievement of specified performance-based conditions, and the actual number of common shares that will ultimately be issued will be determined by multiplying this number of PSUs by a payout percentage ranging from 0% to 100% . Based on the estimated level of achievement of the performance targets associated with the PSUs as of November 30, 2022, unrecognized compensation expense related to the unvested portion of the Company’s RSUs and PSUs was $0.6 million, which is expected to be recognized over a weighted-average period of 2.6 years. Issuance of Shares to Former and Current Executives During the fiscal year ended May 31, 2022, the employment of our CEO and General Counsel was terminated. Under the terms of their respective employment agreements, the Company was obligated to pay severance equal to 18 months of salary to our former CEO and 12 months of salary to our former General Counsel. As permitted by the employment agreements, in March 2022, the Board authorized the severance payments to our former CEO and the remaining severance payments to our former General Counsel to be made through the issuance of shares of common stock. During the six months ended November 30, 2022, the Company issued to our former General Counsel a total of 79,391 shares of common stock to satisfy in full its obligation under the terms of the employment agreement. During the same period, consistent with the terms of our former CEO’s employment agreement, the Company also issued 380,704 shares of common stock as severance. The numbers of shares issued were based on the closing price of the common stock on the applicable date. In order to preserve cash resources, in April 2022, the Board approved the issuance to then executive officers of shares of common stock with a value equal to 25 percent of salary in lieu of cash, net of payroll deductions and withholding taxes. During the six months ended November 30, 2022, a total of 522,382 shares of common stock were issued pursuant to this cash preservation program. The number of shares issued was based on the closing price of the common stock on each payroll date. Private Placement of Warrants under Surety Bond Backstop Agreement On February 14, 2022, the Company entered into a Surety Bond Backstop Agreement (as amended, the “Backstop Agreement”) with an accredited investor, Dr. David Welch, in his individual capacity and as trustee of a revocable trust, as well as certain other related parties (collectively, the “Indemnitors”). Pursuant to the original terms of the Backstop Agreement, the Indemnitors agreed to assist the Company in obtaining a surety bond (the “Surety Bond”) for posting in connection with the Company’s ongoing litigation with Amarex Clinical Research, LLC ("Amarex”) by, among other things, agreeing to indemnify the issuer of the Surety Bond (the “Surety”) with respect to the Company’s obligations under the Surety Bond through August 13, 2022. As consideration for the Indemnitors’ agreement to indemnify the Surety, the Company agreed (i) to issue to 4-Good Ventures LLC, an affiliate of the Indemnitors (“4-Good”), a warrant for the purchase of 15,000,000 shares of common stock as a backstop fee (the “Initial Warrant”), (ii) to issue to 4-Good a warrant for the purchase of an additional 15,000,000 shares, to be exercisable only if the Indemnitors were required to make any payment to the Surety (the “Make-Whole Warrant” and, together with the Initial Warrant, the “4-Good Warrants”), and (iii) if the Indemnitors are required to make a payment to the Surety, (A) within 90 days of such payment, to reimburse the Indemnitors for any amount paid to the Surety and (B) to pay to the Indemnitors an indemnification fee in an amount equal to 1.5 times the amount paid by the Indemnitors to the Surety. The payment obligations of the Company to the Indemnitors will bear interest at 10% per annum and are secured by substantially all of the patents held by the Company. The Company recognized a finance charge of approximately $6.6 million related to the warrant issuance for the fiscal year ended May 31, 2022. Pursuant to amendments to the Backstop Agreement executed in July and December of 2022 (the “Backstop Amendment”), among other matters: (i) each of the 4-Good Warrants has a five-year (iii) the Indemnitors were issued, in December 2022, a fully exercisable warrant to purchase 7,500,000 shares of common stock at an exercise price of $0.10 per share; (iv) the Indemnitors were issued a second warrant in December 2022 covering up to 7,500,000 shares of common stock with an exercise price of $0.10 per share, with the ultimate number of shares to be covered by the second warrant to be calculated on or before February 14, 2023, based on a formula relating to how quickly the Company relieves the balance of cash collateral pledged by the Indemnitors; and (v) provided that the Company will relieve the Indemnitors of a minimum of $1,500,000 of cash collateral currently pledged by the Indemnitors in support of the Surety Bond by January 5, 2023, with the balance of the cash collateral ($5,000,000) to be relieved by January 31, 2023; and provided further that, if the balance of the cash collateral on January 31, 2023, has been reduced to $1,000,000 or less, the Company, in its sole discretion, may elect to require the Indemnitors to accept shares of common stock or warrants to purchase shares of common stock in exchange for the remaining balance. In January 2023, the Indemnitors agreed to extend the relief of the $1,500,000 of cash collateral to January 13, 2023. Liability Classified Warrants Except as described above, the terms of the additional warrants issued in December 2022 are similar to the warrants issued under the original Backstop Agreement, filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on February 17, 2022. The shares covered by the additional warrants are entitled to registration rights. Following the issuance of the additional warrants, Dr. Welch is deemed to beneficially own in excess of five percent of the Company’s outstanding shares of common stock. Private Placement of Common Stock and Warrants through Placement Agent In April 2022, the Company initiated a private placement of common stock and warrants, completed in June 2022, to accredited investors through a placement agent. Between April and June 2022, the Company sold a total of approximately 85.4 million shares of common stock for a total of approximately $18.9 million of proceeds, net of issuance costs. Of these, approximately $7.7 million of proceeds, net of issuance costs, relating to approximately 34.6 million shares were remitted to the Company by May 31, 2022. Each unit sold included a fixed combination of one share of common stock and three-quarters of one warrant to purchase one share of common stock for a purchase price of $0.255 per unit. The Company issued approximately 64.0 million warrants to investors with each such warrant having a five-year term and an exercise price of 120% of the final unit price, or $0.306 per share, and are immediately exercisable. The Company paid the placement agent a total cash fee of approximately $2.8 million, equal to 13% of the gross proceeds of the offering, as well as a one-time fee for expenses of $50,000, and issued a total of approximately 19.4 million warrants with an exercise price of $0.255 per share and a ten-year term, representing 13% of the total number of shares, including shares subject to warrants sold in the offering, to the placement agent and its designees. The issuance of the warrants to the placement agent was subject to the approval by the Company’s stockholders of an increase in authorized shares of common stock, which was approved on August 31, 2022. Down Round Provision Issuance and Modification to Previous Private Offerings During the three months ended August 31, 2022, common stock and warrants previously issued between February and April 2022 to accredited investors directly by the Company in a private placement became subject to a down round provision under the original purchase agreements requiring the Company to reduce the purchase price of common stock from the original price of $0.40 to $0.255 per share, to increase the percentage of the warrant coverage from 50% to 75% based on the revised amount of total shares issued, and to reduce the exercise price of the warrants from the original price of $0.40 to $0.306, the terms in the financing conducted by the Company through the placement agent as described above. As a result, an approximate additional 4.6 million shares of common stock and 5.5 million warrants were issued. The incremental fair value of the warrants were measured using the Black-Scholes pricing model, resulting in an approximately $4.2 million charge to additional paid-in capital which was accounted for as a deemed dividend. Warrant Expiration Extension During the three months ended November 30, 2022, the Company extended the expiration dates of approximately 3.8 million warrants to January 31, 2023. The previous expiration dates for the warrants ranged from September 2022 to December 2022. The modification to these equity instruments resulted in an approximate $0.5 million deemed dividend recorded in equity as of November 30, 2022, and was included in the loss per share calculations for the three- and six-month periods ended November 30, 2022-refer to Note 7, Loss per Common Share Warrant Exercises During the six months ended November 30, 2022, the Company issued approximately 0.5 million shares of common stock in connection with the exercise of an equal number of warrants. The stated exercise prices ranged from $0.45 to $0.75 per share, which resulted in aggregate gross proceeds of approximately $0.3 million. Additionally, during the six months ended November 30, 2022, the Company issued approximately 0.2 million shares of common stock in connection with the cashless exercise of approximately 0.3 million warrants with stated exercise prices ranging from $0.26 to $0.50 per share. Private Warrant Exchanges During the three months ended November 30, 2022, the Company entered into various separate privately negotiated warrant exchange agreements with certain accredited investors, pursuant to which the investors exercised warrants with an original exercise price of $1.00 per share in exchange for the issuance of approximately 9.7 million shares of common stock upon exercise of the warrants, including approximately 8.4 million shares issued as an inducement for the exercises. Gross and net aggregate proceeds from the private warrant exchange were approximately $2.1 million. In connection |
Loss Per Common Share
Loss Per Common Share | 6 Months Ended |
Nov. 30, 2022 | |
Loss Per Common Share | |
Loss Per Common Share | Note 7. Loss per Common Share Basic loss per share is computed by dividing the net loss adjusted for preferred stock dividends by the weighted average number of common shares outstanding during the period. Diluted loss per share includes the weighted average common shares outstanding and potentially dilutive common stock equivalents. Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same since including the additional shares would have an anti-dilutive effect on loss per share. The reconciliation of the numerators and denominators of the basic and diluted net loss per share computations are as follows: Three months ended November 30, Six months ended November 30, (in thousands, except per share amounts) 2022 2021 2022 2021 (Restated) (1) (Restated) (1) Net loss $ (26,495) $ (40,077) $ (47,486) $ (85,414) Less: Deemed dividends (1,140) — (5,294) — Less: Accrued preferred stock dividends (370) (417) (756) (842) Net loss applicable to common stockholders $ (28,005) $ (40,494) $ (53,536) $ (86,256) Basic and diluted: Weighted average common shares outstanding 813,373 662,600 800,545 647,517 Loss per share $ (0.03) $ (0.06) $ (0.07) $ (0.13) (1) See Note 2, Summary of Significant Accounting Policies The table below shows the approximate number of shares of common stock issuable upon the exercise, vesting or conversion of outstanding options, warrants, unvested restricted stock units (including those subject to performance conditions), convertible notes, and convertible preferred stock (including undeclared dividends) that were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the periods presented: Three and six months ended November 30, (in thousands) 2022 2021 Stock options, warrants, and unvested restricted stock units 204,273 73,223 Convertible notes 12,000 12,000 Convertible preferred stock 32,591 34,089 |
Income Taxes
Income Taxes | 6 Months Ended |
Nov. 30, 2022 | |
Income Taxes | |
Income Taxes | Note 8. Income Taxes The Company calculates its quarterly taxes under the effective tax rate method based on applying an anticipated annual effective rate to its year-to-date income, except for discrete items. Income taxes for discrete items are computed and recorded in the period that the specific transaction occurs. The Company’s net tax expense for the three and six months ended November 30, 2022 and 2021 was zero. The Company does not consider it more likely than not that the benefits from the net deferred taxes will be realized; therefore the Company maintains a full valuation allowance as of November 30, 2022 and May 31, 2022, thus creating a difference between the effective tax rate of 0% and the statutory rate of 21%. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Nov. 30, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | Note 9. Commitments and Contingencies Commitments with Samsung BioLogics Co., Ltd. (“Samsung”) In April 2019, the Company entered into an agreement with Samsung, pursuant to which Samsung will perform technology transfer, process validation, manufacturing, pre-approval inspection and supply services for the commercial supply of leronlimab bulk drug substance effective through calendar year 2027. In 2020, the Company entered into an additional agreement, pursuant to which Samsung will perform technology transfer, process validation, vial filling and storage services for clinical, pre-approval inspection, and commercial supply of leronlimab drug product. Samsung is obligated to procure necessary raw materials for the Company and manufacture a specified minimum number of batches, and the Company is required to provide a rolling three-year forecast of future estimated manufacturing requirements to Samsung that are binding. On January 6, 2022, Samsung provided written notice to the Company alleging that the Company had materially breached the parties’ Master Services and Project Specific Agreements for failure to pay $13.5 million due on December 31, 2021. An additional $22.8 million became due under the agreements on January 31, 2022. Under the agreements, Samsung may be entitled to terminate its services if the parties cannot agree on the past-due balance. Management continues to be in ongoing discussions with Samsung regarding potential approaches to resolve these issues, including proposals by both parties of a revised schedule of payments over an extended period, proposals by the Company of satisfaction of a portion of the Company’s payment obligations in equity securities, through future financing, and/or potential licensing opportunities of the Company, proposals to postpone the manufacturing of unfulfilled commitments until a future regulatory approval, and proposals offsetting the unfulfilled commitments with other future potential R&D drug development needs related to the longer-acting therapeutic the Company is currently studying. Samsung has paused manufacturing all unfulfilled commitments not needed by the Company starting in January of 2022. Accordingly, the Company has not recorded any accruals associated with the unfulfilled commitments as of November 30, 2022. In the event negotiations are unsuccessful, the Company may have to accrue a liability related to the unfulfilled commitments. As of November 30, 2022, the Company had past due balances of approximately $35.0 million due to Samsung, which were included in accounts payable. As of November 30, 2022, the future commitments pursuant to these agreements were estimated as follows (in thousands): Fiscal Year Amount 2023 (6 months remaining) $ 34,638 2024 121,750 2025 76,400 2026 and thereafter — Total $ 232,788 Operating Lease Commitments We lease our principal office location in Vancouver, Washington (the “Vancouver Lease”). The Vancouver Lease expires on April 30, 2026. Consistent with the guidance in ASC 842, , we have recorded this lease in our consolidated balance sheet as an operating lease. For the purpose of determining the right of use asset and associated lease liability, we determined that the renewal of the Vancouver lease was not reasonably probable. The lease does not include any restrictions or covenants requiring special treatment under ASC 842, . Operating lease costs for the three months ended November 30, 2022 and 2021 was $46.4 thousand and $48.9 thousand, respectively, and for the six months ended November 30, 2022 and 2021 was approximately $0.1 million and $0.1 million, respectively. Operating lease right-of-use assets are included in other non-current assets and the current portion of operating lease liabilities are included in accrued liabilities and compensation on the consolidated balance sheets. The long-term operating lease liabilities are presented separately as operating lease on the consolidated balance sheets. The following table summarizes the operating lease balances. (in thousands) November 30, 2022 May 31, 2022 Assets Right-of-use asset $ 468 $ 536 Liabilities Current operating lease liability $ 136 $ 134 Non-current operating lease liability 353 422 Total operating lease liability $ 489 $ 556 The minimum (base rental) lease payments are expected to be as follows as of November 30, 2022 (in thousands): Fiscal Year Amount 2023 (6 months remaining) $ 89 2024 182 2025 185 2026 169 Total operating lease payments 625 Less: imputed interest (136) Present value of operating lease liabilities $ 489 Supplemental information related to operating leases was as follows: November 30, 2022 Weighted average remaining lease term 3.4 years Weighted average discount rate 10.0 % Distribution and Licensing Commitments Refer to Note 10, Commitments and Contingencies Legal Proceedings As of November 30, 2022, the Company did not record any legal accruals related to the outcomes of the matters described below. It may not be possible to determine the outcome of these proceedings, including the defense and other litigation-related costs and expenses that may be incurred by the Company, as the outcomes of legal proceedings are inherently uncertain. Therefore, it is possible that the ultimate outcome of any proceeding, if in excess of a recognized accrual, if any, could be material to the Company’s consolidated financial statements. Securities Class Action Lawsuit On March 17, 2021, a stockholder filed a putative class-action lawsuit (the “March 17, 2021 lawsuit”) in the U.S. District Court for the Western District of Washington against the Company and certain former officers. The complaint generally alleges the defendants made false and misleading statements regarding the viability of leronlimab as a potential treatment for COVID-19. On April 9, 2021, a second stockholder filed a similar putative class action lawsuit in the same court, which the plaintiff voluntarily dismissed without prejudice on July 23, 2021. On August 9, 2021, the court appointed lead plaintiffs for the March 17, 2021 lawsuit. On December 21, 2021, lead plaintiffs filed an amended complaint, which is brought on behalf of an alleged class of those who purchased the Company’s common stock between March 27, 2020 and May 17, 2021. The amended complaint generally alleges that the defendants violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making purportedly false or misleading statements concerning, among other things, the safety and efficacy of leronlimab as a potential treatment for COVID-19, the Company’s CD10 and CD12 clinical trials, and its HIV BLA. The amended complaint also alleges that the individual defendants violated Section 20A of the Exchange Act by selling shares of the Company’s common stock purportedly while in possession of material nonpublic information. The amended complaint seeks, among other relief, a ruling that the case may proceed as a class action and unspecified damages and attorneys’ fees and costs. On February 25, 2022, the defendants filed a motion to dismiss the amended complaint. On June 24, 2022, lead plaintiffs filed a second amended complaint. The second amended complaint is brought on behalf of an alleged class of those who purchased the Company’s common stock between March 27, 2020 and March 30, 2022, makes similar allegations, names the same defendants, and asserts the same claims as the prior complaint, adds a claim for alleged violation of Section 10(b) of the Exchange Act and Rule 10b-5(a) and (c) promulgated thereunder, and seeks the same relief as the prior complaint. The Company and the individual defendants deny all allegations of wrongdoing in the complaint and intend to vigorously defend the matter. Since this case is in an early stage where the number of plaintiffs is not known, and the claims do not specify an amount of damages, the Company is unable to predict the ultimate outcome of the lawsuit and cannot reasonably estimate the potential loss or range of loss the Company may incur. 2021 Shareholder Derivative Lawsuits On June 4, 2021, a stockholder filed a purported derivative lawsuit against certain of the Company’s former officers and directors, and the Company as a nominal defendant, in the U.S. District Court for the Western District of Washington. Two additional shareholder derivative lawsuits were filed against the same defendants in the same court on June 25, 2021 and August 18, 2021, respectively. The court has consolidated these three lawsuits for all purposes (“Consolidated Derivative Suit”). On January 20, 2022, the plaintiffs filed a consolidated complaint. The consolidated complaint generally alleges that the director defendants breached their fiduciary duties by allowing the Company to make false and misleading statements regarding, among other things, the safety and efficacy of leronlimab as a potential treatment for COVID-19, the Company’s CD10 and CD12 clinical trials, and its HIV BLA, and by failing to maintain an adequate system of oversight and controls. The consolidated complaint also asserts claims against one or more individual defendants for waste of corporate assets, unjust enrichment, contribution for alleged violations of the federal securities laws, and for breach of fiduciary duty arising from alleged insider trading. The consolidated complaint seeks declaratory and equitable relief, an unspecified amount of damages, and attorneys’ fees and costs. The Company and the individual defendants deny all allegations of wrongdoing in the complaints and intend to vigorously defend the litigation. In light of the fact that the Consolidated Derivative Suit is in an early stage and the claims do not specify an amount of damages, the Company cannot predict the ultimate outcome of the Consolidated Derivative Suit and cannot reasonably estimate the potential loss or range of loss the Company may incur. Securities and Exchange Commission and Department of Justice Investigations The Company has received subpoenas from the United States Securities and Exchange Commission (“SEC”) and the United States Department of Justice (“DOJ”) requesting documents and information concerning, among other matters, leronlimab, the Company’s public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, the Company’s retention of investor relations consultants, and trading in the Company’s securities. Certain former Company executives and directors have received subpoenas concerning similar issues and have been interviewed by the DOJ and SEC, including the Company’s former CEO, Nader Z. Pourhassan. On January 24, 2022, Mr. Pourhassan was terminated and removed from the Board of Directors and has had no role at the Company since. On December 20, 2022, the DOJ announced the unsealing of a criminal indictment charging both Mr. Pourhassan, and Kazem Kazempour, CEO of Amarex Clinical Research LLC, a subsidiary of NSF International, Inc., CRO. Mr. Pourhassan was charged with one count of conspiracy, four counts of securities fraud, three counts of wire fraud, and three counts of insider trading. Mr. Kazempour was charged with one count of conspiracy, three counts of securities fraud, two counts of wire fraud, and one count of making a false statement. That same day, the SEC announced charges against both Mr. Pourhassan and Mr. Kazempour for alleged violations of federal securities laws. The Company is committed to cooperating fully with the DOJ and SEC investigations, which are ongoing, and which the Company’s counsel frequently engages with them on. Further, the Company has made voluminous productions of information and made witnesses available for voluntary interviews. The Company will continue to comply with the requests of the SEC and DOJ. The Company cannot predict the ultimate outcome of the DOJ and SEC investigations or the case against Mr. Pourhassan, nor can it predict whether any other governmental authorities will initiate separate investigations or litigation. The investigations and any related legal and administrative proceedings could include a wide variety of outcomes, including the institution of administrative, civil injunctive or criminal proceedings involving the Company and/or former executives and/or former directors in addition to Mr. Pourhassan, the imposition of fines and other penalties, remedies and/or sanctions, modifications to business practices and compliance programs and/or referral to other governmental agencies for other appropriate actions. It is not possible to accurately predict at this time when matters relating to the investigations will be completed, the final outcome of the investigations, what additional actions, if any, may be taken by the DOJ or SEC or by other governmental agencies, or the effect that such actions may have on our business, prospects, operating results and financial condition, which could be material. The DOJ and SEC investigations, including any matters identified in the investigations and indictments, could also result in (1) third-party claims against the Company, which may include the assertion of claims for monetary damages, including but not limited to interest, fees, and expenses, (2) damage to the Company's business or reputation, (3) loss of, or adverse effect on, cash flow, assets, results of operations, business, prospects, profits or business value, including the possibility of certain of the Company's existing contracts being cancelled, (4) adverse consequences on the Company's ability to obtain or continue financing for current or future projects and/or (5) claims by directors, officers, employees, affiliates, advisors, attorneys, agents, debt holders or other interest holders or constituents of the Company or its subsidiaries, any of which could have a material adverse effect on the Company's business, prospects, operating results and financial condition. Further, to the extent that these investigations and any resulting third-party claims yield adverse results over time, such results could jeopardize the Company's operations and exhaust its cash reserves, and could cause stockholders to lose their entire investment Amarex Dispute On October 4, 2021, the Company filed a complaint for declaratory and injunctive relief and a motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research LLC (“Amarex”), the Company’s former CRO. Over the past eight years, Amarex provided clinical trial management services to the Company and managed numerous clinical studies of the Company’s drug product candidate, leronlimab. On December 16, 2021, the U.S. District Court for the District of Maryland issued a preliminary injunction requiring Amarex to provide the Company with access to all of its materials in the possession of Amarex. The court also granted CytoDyn the right to conduct an audit of Amarex’s work for CytoDyn. That case has been administratively closed. The Company simultaneously filed a demand for arbitration with the American Arbitration Association. The arbitration demand alleges that Amarex failed to perform services to an acceptable professional standard and failed to perform certain services required by the parties’ agreements. Further, the demand alleges that Amarex billed the Company for services it did not perform. The Company contends that, due to Amarex’s failures, it has suffered avoidable delays in obtaining regulatory approval of leronlimab and has paid for services not performed. Amarex has counterclaimed alleging that CytoDyn has failed to pay invoices due under the contract between the parties. In light of the fact that this dispute is in an early stage, the Company cannot predict the ultimate outcome of the lawsuit and cannot reasonably estimate the potential loss or range of loss that the Company may incur. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Nov. 30, 2022 | |
Subsequent Events | |
Subsequent Events | Note 10. Subsequent Events During December 2022, in satisfaction of redemptions, the Company and the April 2, 2021 Note holder entered into exchange agreements, pursuant to which portions of the April 2, 2021 Note were partitioned into new notes (the “December Partitioned Notes”) with an aggregate principal amount of $1.0 million, which were exchanged concurrently with the issuance of approximately 4.7 million shares of common stock. The outstanding balance of the April 2, 2021 Note was reduced by the December Partitioned Notes to a principal amount of $8.3 million. During December 2022, the Company entered into various separate privately negotiated warrant exchange agreements with certain accredited investors, pursuant to which the investors exercised warrants with an original exercise price of $0.50 - $0.75 per share in exchange for the issuance of approximately 3.4 million shares of common stock upon exercise of the warrants, including approximately 0.6 million shares issued as an inducement for the exercises. Gross and net aggregate proceeds from the private warrant exchange were approximately $0.7 million. As of November 30, 2022 the Company held $0.2 million in restricted cash related to these transactions. In January 2023, the Company commenced an offering of units seeking to raise up to $15.0 million in gross proceeds, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock. The offering is being conducted in a private placement through a placement agent in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated by the SEC thereunder. The securities being offered will not be registered for resale under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The intended use of proceeds is to fund operations and for general corporate purposes, including the reduction of indebtedness. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Nov. 30, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The unaudited interim consolidated financial statements include the accounts of CytoDyn Inc. and its wholly owned subsidiaries, CytoDyn Operations Inc. and Advanced Genetic Technologies, Inc. (“AGTI”); AGTI is a dormant entity. The consolidated financial statements reflect all normal recurring adjustments which are, in the opinion of management, necessary for a fair statement of the results of operations for the interim financial statements. The interim financial information and notes thereto should be read in conjunction with the Company's latest Annual Report on Form 10-K for the fiscal year ended May 31, 2022 (the “2022 Form 10-K”) The results of operations for the periods presented are not necessarily indicative of results to be expected for the entire fiscal year or for any other future annual or interim period. |
Reclassifications | Reclassifications Certain prior year and prior quarter amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the current period presentation. Such reclassifications did not have material effect on the Company’s previously reported financial position, results of operations, stockholders’ deficit, or net cash provided by operating activities. During the quarter ended August 31, 2022, the Company reclassified amounts recorded as accumulated dividends for Series C and D preferred stockholders from accumulated deficit to additional paid-in capital. These reclassifications were made to reflect the proper presentation for accrued dividends when an entity has accumulated deficit. |
Revision and Restatement of Financial Statements | Revision and Restatement of Financial Statements During the preparation of the quarterly financial statements as of and for the period ended November 30, 2021, the Company identified an error in how non-cash inducement interest expense was calculated in previous reporting periods dating back to fiscal year 2018. The error resulted in an understatement of non-cash inducement interest expense and additional paid-in capital. For details, refer to Note 2, Summary of Significant Accounting Policies - Revision of Financial Statements in the 2022 Form 10-K. Also, during the preparation and audit of the annual financial statements as of and for the fiscal year ended May 31, 2022, the Company concluded that a material error was identified in how the Company was accounting for common stock issued to settle certain convertible note obligations dating back to fiscal year 2021. For details, refer to Note 14, Restatement in the 2022 Form 10-K. Neither of the errors had impact on operating loss, cash, net cash used in or provided by operating, financing, and investing activities, assets, liabilities, commitments and contingencies, total stockholders’ deficit, number of shares issued and outstanding, basic and diluted weighted average common shares outstanding, and number of shares available for future issuance for any period presented, and are reflected in the accompanying statement of operations, changes in stockholders’ deficit, and statement of cash flows. |
Going Concern | Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As presented in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of approximately $47.5 million for the six months ended November 30, 2022 and has an accumulated deficit of approximately $809.4 million as of November 30, 2022. These factors, among several others, including the various legal matters discussed in Note 9, Commitments and Contingencies – Legal Proceedings The Company’s continuance as a going concern is dependent upon its ability to obtain additional operating capital, complete the development of its product candidate, leronlimab, obtain approval to commercialize leronlimab from regulatory agencies, continue to outsource manufacturing of leronlimab, and ultimately achieve revenues and attain profitability. The Company plans to continue to engage in research and development activities related to leronlimab for multiple indications and expects to incur significant research and development expenses in the future, primarily related to its regulatory compliance, including seeking the lifting of the FDA’s clinical hold with regard to the Company’s HIV program, performing additional clinical trials, and seeking regulatory approval for its product candidate for commercialization. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs primarily from the sale of equity and debt securities, combined with additional funding from other sources. However, there can be no assurance that the Company will be successful in these endeavors. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in accordance with accounting principles generally accepted in the United States (U.S. GAAP) requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Estimates are assessed each period and updated to reflect current information, such as the status of our analysis of the results of our clinical trials and/or discussions with the FDA which could have an impact on the Company’s significant accounting estimates and assumptions. The Company’s estimates are based on historical experience and on various market and other relevant, appropriate assumptions. Significant estimates include, but are not limited to, those relating to capitalization of pre-launch inventories, charges for excess and obsolete inventories, research and development expenses, commitments and contingencies, stock-based compensation, and the assumptions used to value warrants and warrant modifications. Actual results could differ from these estimates. |
Pre-launch Inventories | Pre-launch Inventories Pre-launch inventories were comprised of raw materials required to commercially produce leronlimab and substantially completed commercially produced leronlimab in anticipation of commercial sales of the product upon potential regulatory approval as a combination therapy for HIV patients in the United States. The Company’s pre-launch inventories consisted of (1) raw materials purchased for commercial production, (2) work-in-progress materials which consisted of bulk drug substance, which was the manufactured drug stored in bulk storage, and (3) drug product, which was the manufactured drug in unlabeled vials. The consumption of raw materials during production was classified as work-in-progress until saleable. Once it is determined to be in saleable condition, following regulatory approval, inventory is classified as finished goods. The Company capitalizes inventories procured or produced in preparation for product launches. Typically, capitalization of such inventory begins when the results of clinical trials have reached a status sufficient to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced, and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The material factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and status of the Company’s regulatory applications. The Company closely monitors the status of the product within the regulatory review and approval process, including all relevant communications with regulatory authorities. If the Company becomes aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, it may make a determination that the related inventory no longer qualifies for capitalization. The Company determines whether raw materials purchased for commercial production are usable for production based on the manufacturer’s assigned expiration date. In evaluating whether raw materials included in the pre-launch inventories will be usable for production, the Company takes into account the shelf-life of raw materials at the time they are expected to be used in manufacturing. Any raw materials past expiration date at the time of the next manufacturing run are removed from inventory. As one stage of the manufacturing process, the Company produces work-in-progress materials which consist of bulk drug substance, which is the manufactured drug stored in bulk storage. The initial shelf-life of bulk drug substance is established based on prior experience and periodically performed stability studies and is set at four years from the date of manufacturing. Bulk drug substance is subject to deep freeze storage, and stability studies are performed on a periodic basis in accordance with the established stability protocols. If drug substance meets suitability criteria beyond the initial shelf-life, its shelf-life may be extended based on prior experience and stability trend analysis, and during the extension period periodic stability testing is performed on the drug substance. Regardless of the number of stability studies performed, if drug substance continues to meet prespecified suitability parameters it may be used in manufacturing; if drug substance fails to meet suitability criteria beyond its assigned shelf-life at that time, it may no longer be used and is considered to be expired. The Company utilizes resins, a reusable raw material, in its bulk drug manufacturing process. Shelf-life of a resin used in commercial manufacturing of biologics is determined by the number of cycles for which it has been validated to be used in a manufacturing process before it is considered unusable. Unpacked and unused resins have a manufacturer’s expiration date by which resins are expected to start being used in the manufacturing process without loss of their properties. Prior to a new manufacturing campaign, and between manufacturing campaigns, the resins are removed from storage, and are treated and tested for suitability. Once resins are used in the manufacturing process, their shelf-life is measured by a validated predetermined number of manufacturing cycles they are usable for, conditional on appropriate storage solution under controlled environment between production campaigns, as well as by performing pre-production usability testing. Before a manufacturing campaign, each resin is tested for suitability. Regardless of the number of cycles, if a resin fails to meet prespecified suitability parameters it may not be used in manufacturing; likewise, even if the resin meets suitability criteria beyond the lifetime cycles, it may no longer be used. The cost of the resins used in a manufacturing campaign is allocated to the cost of the drug product in vials. The Company values its inventory at the lower of cost or net realizable value using the average cost method. Inventory is evaluated for recoverability by considering the likelihood that revenue will be obtained from the future sale of the related inventory considering the status of the product within the regulatory approval process. The Company evaluates its inventory levels on a quarterly basis and writes down inventory that became obsolete, has a cost in excess of its expected net realizable value, or is in quantities in excess of expected requirements. In assessing the lower of cost or net realizable value for pre-launch inventory, the Company relies on independent analyses provided by third parties knowledgeable about the range of likely commercial prices comparable to current comparable commercial product. Quarterly, the Company also evaluates whether certain raw materials held in its inventory are expected to reach the end of their estimated shelf-lives based on passage of time, the number of manufacturing cycles they are used in and results of pre-production testing prior to the expected production date, or when resins used in the manufacturing process fail suitability tests. If any of such events occur, the Company may make a determination to record a charge if it is expected that such inventories will become obsolete prior to the expected production date. Anticipated future sales, shelf lives, and expected approval date are considered when evaluating realizability of capitalized inventory. The shelf-life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventories, the Company considers the product stability data for all of the pre-approval inventory procured or produced to date to determine whether there is adequate shelf-life. When the remaining shelf-life of drug product inventory is less than 12 months, it is likely that it will not be accepted by potential customers. However, as inventories approach their shelf-life expiration, the Company may perform additional stability testing to determine if the inventory is still viable, which can result in an extension of its shelf-life and revaluation of the need for and the amount of the previously recorded reserves. Further, in addition to performing additional stability testing, certain raw materials inventory may be sold in its then current condition prior to reaching expiration. If the Company determines that it is not likely that shelf-life may be extended or the inventory cannot be sold prior to expiration, the Company may record a charge to bring inventory to its net realizable value. In October 2022, the Company voluntarily withdrew its BLA submission after concluding that a significant risk existed that the BLA would not receive FDA approval due to the inadequate process and performance by its former CRO around the monitoring and oversight of the clinical data from its trials. Following this decision, none of the Company’s inventories now qualify for capitalization as pre-launch inventories. See Note 3, Inventories, net For additional information about the Company’s significant accounting policies, refer to Note 2, Summary of Significant Accounting Policies, |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) retrospective method of transition is permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted ASU No. 2020-06 as of June 1, 2022, using the modified retrospective method. The adoption of ASU No. 2020-06 had no impact on the Company’s balance sheets, statements of operations, cash flows or financials statement disclosures. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation - Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options The Company adopted the new guidance prospectively as of June 1, 2022 and used the framework to record a modification to equity classified warrants during the six months ended November 30, 2022. The modification to equity instruments, consisting of a trigger of a down round provision was recorded as a deemed dividend in accordance with this guidance, resulting in an approximate $4.2 million charge to additional paid-in capital, induced warrant exercises recorded as $2.1 million issuance cost and $0.5 million deemed dividend, and the extension of warrant expiration dates recorded as a $0.5 million deemed dividend. The deemed dividends were included in the loss per share calculation; refer to Note 7 , Loss per Common Share , Equity Awards and Warrants |
Inventories, net (Tables)
Inventories, net (Tables) | 6 Months Ended |
Nov. 30, 2022 | |
Inventories, net | |
Summary of Inventories, net of reserves | Inventories were as follows (in thousands): November 30, 2022 May 31, 2022 Raw materials $ — $ 16,264 Work-in-progress — 1,665 Total inventories, net $ — $ 17,929 |
Schedule of remaining shelf life of inventory | Raw Materials Work-in-progress (in thousands, Expiration period ending November 30,) Remaining shelf-life (mos) Specialized Resins Other Total Raw Materials Bulk drug product Finished drug product Total inventories 2023 0 to 12 $ 4,764 $ 16,264 $ - $ 21,028 $ - $ - $ 21,028 2024 13 to 24 2,511 - 1,590 4,101 1,661 29,142 34,904 2025 25 to 36 189 - - 189 - 32,343 32,532 2026 37 to 48 2,115 - - 2,115 - - 2,115 Thereafter 49 or more - - - - - - - Inventories, gross 9,579 16,264 1,590 27,433 1,661 61,485 90,579 Inventory charge (9,579) (16,264) (1,590) (27,433) (1,661) (61,485) (90,579) Inventories, net $ - $ - $ - $ - $ - $ - $ - |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 6 Months Ended |
Nov. 30, 2022 | |
Accounts Payable and Accrued Liabilities | |
Schedule of components of accrued liabilities | The components of accrued liabilities are as follows (in thousands): November 30, 2022 May 31, 2022 Compensation and related expense $ 496 $ 1,522 Legal fees and settlement 166 2,006 Clinical expense 1,176 3,727 Accrued inventory charges and expenses 3,155 1,392 License fees 393 150 Lease payable 136 134 Other liabilities 200 64 Total accrued liabilities $ 5,722 $ 8,995 |
Convertible Instruments and A_2
Convertible Instruments and Accrued Interest (Tables) | 6 Months Ended |
Nov. 30, 2022 | |
Convertible Instruments and Accrued Interest | |
Schedule of information on dividends of convertible preferred stock | November 30, 2022 May 31, 2022 (in thousands) Series B Series C Series D Series B Series C Series D Shares of preferred stock 19 6 9 19 7 9 Total shares of common stock if converted 190 12,670 10,565 190 13,806 10,565 Undeclared dividends $ 12 $ - $ - $ 10 $ - $ - Accrued dividends $ - $ 2,184 $ 2,387 $ - $ 2,014 $ 1,963 Total shares of common stock if dividends converted 25 4,368 4,774 20 4,028 3,926 |
Schedule of outstanding balances of convertible notes | November 30, 2022 May 31, 2022 (in thousands) April 2, 2021 Note April 23, 2021 Note Total April 2, 2021 Note April 23, 2021 Note Total Convertible notes payable outstanding principal $ 9,319 $ 28,500 $ 37,819 $ 9,819 $ 28,500 $ 38,319 Less: Unamortized debt discount and issuance costs (198) (690) (888) (512) (1,566) (2,078) Convertible notes payable, net 9,121 27,810 36,931 9,307 26,934 36,241 Accrued interest on convertible notes 3,242 5,037 8,279 2,599 3,375 5,974 Outstanding convertible notes payable, net and accrued interest $ 12,363 $ 32,847 $ 45,210 $ 11,906 $ 30,309 $ 42,215 |
Schedule of reconciliation of changes to outstanding balance of convertible notes | (in thousands) April 2, 2021 Note April 23, 2021 Note Total Outstanding balance at May 31, 2022 $ 11,906 $ 30,309 $ 42,215 Amortization of issuance discount and costs 314 876 1,190 Interest expense 643 1,662 2,305 Fair market value of shares exchanged for repayment (638) - (638) Difference between market value of 138 - 138 Outstanding balance at November 30, 2022 $ 12,363 $ 32,847 $ 45,210 |
Equity Awards and Warrants (Tab
Equity Awards and Warrants (Tables) | 6 Months Ended |
Nov. 30, 2022 | |
Equity Awards and Warrants | |
Schedule of warrant liability and equity | (in thousands) Liability Classified Warrants Balance at May 31, 2022 $ — Classified as liability due to lack of shares availability at issuance 14,522 Classified as equity upon increase in availability (23,123) Loss on derivative due to change in fair market value 8,601 Balance at August 31, 2022 $ — |
Schedule of assumptions used in determination of fair value | Initial Fair Market Value At Issuance Fair Market Value at August 31, 2022 Backstop Backstop Placement Backstop Backstop Placement Warrant #1 Warrant #2 Agent Warrants Warrant #1 Warrant #2 Agent Warrants Fair value of underlying stock $ 0.44 $ 0.42 $ 0.44 $ 0.52 $ 0.52 $ 0.52 Risk free rate 3.17% 3.06% 3.13% 3.34% 3.31% 3.16% Expected term (in years) 4.65 5.00 10.00 4.46 4.88 9.82 Stock price volatility 110.20% 109.49% 95.99% 117.29% 113.59% 95.87% Expected dividend yield 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% |
Stock Option and Warrant Activity | Weighted average Weighted remaining Aggregate Number of average contractual intrinsic (in thousands, except per share data) shares exercise price life in years value Options and warrants outstanding at May 31, 2022 90,705 $ 0.77 4.06 $ 352 Granted 116,439 $ 0.29 Exercised (2,097) $ 0.79 Forfeited, expired, and cancelled (2,147) $ 1.49 Options and warrants outstanding at November 30, 2022 202,900 $ 0.48 4.80 $ 9,616 Options and warrants outstanding and exercisable at November 30, 2022 189,085 $ 0.47 4.48 $ 9,540 |
Schedule of Company RSU and PSU activity | Number of Weighted-average (in thousands, except per share data) RSUs and PSUs (1) grant date fair value Unvested RSUs and PSUs at May 31, 2022 300 $ 3.12 RSUs and PSUs granted 1,293 0.58 Unvested RSUs and PSUSs forfeited (67) 3.12 RSUs and PSUs vested (150) 3.12 Unvested RSUs and PSUs at November 30, 2022 1,376 $ 0.73 ( 1 The number of PSUs disclosed in this table are at the target level of 100%. |
Loss Per Common Shares (Tables)
Loss Per Common Shares (Tables) | 6 Months Ended |
Nov. 30, 2022 | |
Loss Per Common Share | |
Schedule of reconciliation of the numerators and denominators of basic and diluted net loss per share | Three months ended November 30, Six months ended November 30, (in thousands, except per share amounts) 2022 2021 2022 2021 (Restated) (1) (Restated) (1) Net loss $ (26,495) $ (40,077) $ (47,486) $ (85,414) Less: Deemed dividends (1,140) — (5,294) — Less: Accrued preferred stock dividends (370) (417) (756) (842) Net loss applicable to common stockholders $ (28,005) $ (40,494) $ (53,536) $ (86,256) Basic and diluted: Weighted average common shares outstanding 813,373 662,600 800,545 647,517 Loss per share $ (0.03) $ (0.06) $ (0.07) $ (0.13) (1) See Note 2, Summary of Significant Accounting Policies |
Schedule of securities excluded from computation of earnings per share | Three and six months ended November 30, (in thousands) 2022 2021 Stock options, warrants, and unvested restricted stock units 204,273 73,223 Convertible notes 12,000 12,000 Convertible preferred stock 32,591 34,089 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Nov. 30, 2022 | |
Commitments and Contingencies. | |
Schedule of future commitments | Fiscal Year Amount 2023 (6 months remaining) $ 34,638 2024 121,750 2025 76,400 2026 and thereafter — Total $ 232,788 |
Schedule of operating lease balances | (in thousands) November 30, 2022 May 31, 2022 Assets Right-of-use asset $ 468 $ 536 Liabilities Current operating lease liability $ 136 $ 134 Non-current operating lease liability 353 422 Total operating lease liability $ 489 $ 556 |
Schedule of the minimum (base rental) lease payments | The minimum (base rental) lease payments are expected to be as follows as of November 30, 2022 (in thousands): Fiscal Year Amount 2023 (6 months remaining) $ 89 2024 182 2025 185 2026 169 Total operating lease payments 625 Less: imputed interest (136) Present value of operating lease liabilities $ 489 |
Schedule of supplemental information relating to operating leases | Fiscal Year Amount 2023 (6 months remaining) $ 89 2024 182 2025 185 2026 169 Total operating lease payments 625 Less: imputed interest (136) Present value of operating lease liabilities $ 489 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||||
Nov. 30, 2022 | Aug. 31, 2022 | Nov. 30, 2021 | [1],[2] | Aug. 31, 2021 | [2] | Nov. 30, 2022 | Nov. 30, 2021 | [1],[2] | May 31, 2022 | |
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Net loss | $ 26,495 | $ 20,991 | $ 40,077 | $ 45,337 | $ 47,486 | $ 85,414 | ||||
Accumulated deficit | $ 809,352 | 809,352 | $ 766,131 | |||||||
Charge to APIC due to warrant modification | 4,200 | |||||||||
Debt issuance costs | 2,100 | |||||||||
Warrant expirations deemed dividend | 500 | |||||||||
Extension of warrant expirations deemed dividend | $ 500 | |||||||||
Bulk Drug Substance | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Shelf life | 4 years | |||||||||
[1] See Note 2, Summary of Significant Accounting Policies See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |
Inventories, net (Details)
Inventories, net (Details) $ in Thousands | May 31, 2022 USD ($) |
Inventories, net | |
Raw materials | $ 16,264 |
Work-in-progress | 1,665 |
Inventories, net | $ 17,929 |
Inventories, net - Shelf-life (
Inventories, net - Shelf-life (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Nov. 30, 2022 | Nov. 30, 2021 | [1] | Nov. 30, 2022 | Nov. 30, 2021 | [1] | May 31, 2022 | Feb. 28, 2022 | |
Inventory Realizable Value | ||||||||
2023 | $ 21,028 | $ 21,028 | ||||||
2024 | 34,904 | 34,904 | ||||||
2025 | 32,532 | 32,532 | ||||||
2026 | 2,115 | 2,115 | ||||||
Inventories, gross | 90,579 | 90,579 | ||||||
Inventory charge | (90,579) | (90,579) | ||||||
Inventories, net | $ 17,929 | |||||||
Raw materials | $ 16,264 | |||||||
Inventory charged-off | 17,929 | $ 1,593 | 20,633 | $ 3,357 | ||||
Other Assets | Samsung BioLogics Co., Ltd. ("Samsung") | ||||||||
Inventory Realizable Value | ||||||||
Specialized raw materials | $ 2,700 | |||||||
Raw Materials | ||||||||
Inventory Realizable Value | ||||||||
2023 | 21,028 | 21,028 | ||||||
2024 | 4,101 | 4,101 | ||||||
2025 | 189 | 189 | ||||||
2026 | 2,115 | 2,115 | ||||||
Inventories, gross | 27,433 | 27,433 | ||||||
Inventory charge | (27,433) | (27,433) | ||||||
Specialized | ||||||||
Inventory Realizable Value | ||||||||
2023 | 4,764 | 4,764 | ||||||
2024 | 2,511 | 2,511 | ||||||
2025 | 189 | 189 | ||||||
2026 | 2,115 | 2,115 | ||||||
Inventories, gross | 9,579 | 9,579 | ||||||
Inventory charge | (9,579) | (9,579) | ||||||
Resins | ||||||||
Inventory Realizable Value | ||||||||
2023 | 16,264 | 16,264 | ||||||
Inventories, gross | 16,264 | 16,264 | ||||||
Inventory charge | (16,264) | (16,264) | ||||||
Inventory charged-off | 16,300 | |||||||
Other | ||||||||
Inventory Realizable Value | ||||||||
2024 | 1,590 | 1,590 | ||||||
Inventories, gross | 1,590 | 1,590 | ||||||
Inventory charge | (1,590) | (1,590) | ||||||
Bulk Drug Substance | ||||||||
Inventory Realizable Value | ||||||||
2024 | 1,661 | 1,661 | ||||||
Inventories, gross | 1,661 | 1,661 | ||||||
Inventory charge | (1,661) | $ (1,661) | ||||||
Inventory charged-off | 1,700 | |||||||
Shelf life | 4 years | |||||||
Drug Products | ||||||||
Inventory Realizable Value | ||||||||
2024 | 29,142 | $ 29,142 | ||||||
2025 | 32,343 | 32,343 | ||||||
Inventories, gross | 61,485 | 61,485 | ||||||
Inventory charge | $ (61,485) | $ (61,485) | ||||||
[1] See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Details) $ in Thousands | 6 Months Ended | 12 Months Ended |
Nov. 30, 2022 USD ($) item | May 31, 2022 USD ($) | |
Accounts Payable and Accrued Liabilities | ||
Accounts payable | $ 67,187 | $ 67,974 |
Number of vendors | item | 2 | |
Compensation and related expense | $ 496 | 1,522 |
Legal fees and settlement | 166 | 2,006 |
Clinical expenses | 1,176 | 3,727 |
Accrued inventory charges and expenses | 3,155 | 1,392 |
License fees | 393 | 150 |
Lease payable | 136 | 134 |
Other liabilities | 200 | 64 |
Total accrued liabilities | $ 5,722 | $ 8,995 |
Accounts Payable | Credit Availability Concentration Risk | Vendor One | ||
Accounts Payable and Accrued Liabilities | ||
Concentration Risk, Percentage | 70% | |
Accounts Payable | Credit Availability Concentration Risk | Vendor Two | ||
Accounts Payable and Accrued Liabilities | ||
Concentration Risk, Percentage | 73% |
Convertible Instruments and A_3
Convertible Instruments and Accrued Interest - Preferred stock (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended | 12 Months Ended |
Nov. 30, 2022 | May 31, 2022 | |
Class of Stock [Line Items] | ||
Accrued dividends | $ 4,571 | $ 3,977 |
Series B Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Shares of preferred stock | 19 | 19 |
Total shares of common stock if converted | 190 | 190 |
Undeclared dividend | $ 12 | $ 10 |
Total shares of common stock if dividends converted | 25 | 20 |
Preferred stock dividend, value per share | $ 0.25 | |
Preferred stock, stated value per share | 5 | |
Preferred stock conversion price, per share | $ 0.50 | |
Undeclared dividend, shares | 10 | |
Series C Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Shares of preferred stock | 6 | 7 |
Total shares of common stock if converted | 12,670 | 13,806 |
Accrued dividends | $ 2,184 | $ 2,014 |
Total shares of common stock if dividends converted | 4,368 | 4,028 |
Preferred stock dividend, value per share | $ 0.50 | |
Series D Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Shares of preferred stock | 9 | 9 |
Total shares of common stock if converted | 10,565 | 10,565 |
Accrued dividends | $ 2,387 | $ 1,963 |
Total shares of common stock if dividends converted | 4,774 | 3,926 |
Preferred stock dividend, value per share | $ 0.80 | |
Series C and Series D Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Preferred stock dividend rate, as a percent | 10% | |
Preferred stock, stated value per share | $ 1,000 |
Convertible Instruments and A_4
Convertible Instruments and Accrued Interest - Outstanding Balance (Details) - USD ($) $ in Thousands | Nov. 30, 2022 | May 31, 2021 |
Debt Instrument [Line Items] | ||
Convertible notes payable outstanding principal | $ 37,819 | $ 38,319 |
Less: Unamortized debt discount and issuance costs | (888) | (2,078) |
Convertible notes payable, net | 36,931 | 36,241 |
Accrued interest on convertible notes | 8,279 | 5,974 |
Outstanding convertible notes payable, net and accrued interest | 45,210 | 42,215 |
Long-term Convertible Note - April 2, 2021 Note | ||
Debt Instrument [Line Items] | ||
Convertible notes payable outstanding principal | 9,319 | 9,819 |
Less: Unamortized debt discount and issuance costs | (198) | (512) |
Convertible notes payable, net | 9,121 | 9,307 |
Accrued interest on convertible notes | 3,242 | 2,599 |
Outstanding convertible notes payable, net and accrued interest | 12,363 | 11,906 |
Long-term Convertible Note - April 23, 2021 Note | ||
Debt Instrument [Line Items] | ||
Convertible notes payable outstanding principal | 28,500 | 28,500 |
Less: Unamortized debt discount and issuance costs | (690) | (1,566) |
Convertible notes payable, net | 27,810 | 26,934 |
Accrued interest on convertible notes | 5,037 | 3,375 |
Outstanding convertible notes payable, net and accrued interest | $ 32,847 | $ 30,309 |
Convertible Instruments and A_5
Convertible Instruments and Accrued Interest - Components (Details) $ in Thousands | 6 Months Ended |
Nov. 30, 2022 USD ($) | |
Debt Instrument [Line Items] | |
Outstanding balance, beginning | $ 42,215 |
Amortization of issuance discount and costs | 1,190 |
Interest expense | 2,305 |
Fair market value of shares exchanged for repayment | (638) |
Difference between market value of common shares and reduction of principle | 138 |
Outstanding balance, ending | 45,210 |
Long-term Convertible Note - April 2, 2021 Note | |
Debt Instrument [Line Items] | |
Outstanding balance, beginning | 11,906 |
Amortization of issuance discount and costs | 314 |
Interest expense | 643 |
Fair market value of shares exchanged for repayment | (638) |
Difference between market value of common shares and reduction of principle | 138 |
Outstanding balance, ending | 12,363 |
Long-term Convertible Note - April 23, 2021 Note | |
Debt Instrument [Line Items] | |
Outstanding balance, beginning | 30,309 |
Amortization of issuance discount and costs | 876 |
Interest expense | 1,662 |
Outstanding balance, ending | $ 32,847 |
Convertible Instruments and A_6
Convertible Instruments and Accrued Interest - Long-term Convertible Note - April 2, 2021 Note (Detail) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Apr. 02, 2021 | Nov. 30, 2022 | Nov. 30, 2022 | Nov. 30, 2021 | May 31, 2022 | May 31, 2021 | |
Debt Instrument [Line Items] | ||||||
Debt issuance costs | $ 2,100 | |||||
Amortization of issuance discount and costs | 1,190 | |||||
Net carrying value of note | $ 45,210 | 45,210 | $ 42,215 | |||
Loss on induced conversion | 600 | 600 | $ 6,800 | |||
Long-term Convertible Note - April 2, 2021 Note | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument term | 2 years | |||||
Convertible note, aggregate principal | $ 28,500 | 9,300 | 9,300 | |||
Net Proceeds | 25,000 | |||||
Unamortized discount | 3,400 | |||||
Debt issuance costs | 100 | |||||
Conversion of principal and interest of convertible notes to common stock | $ 3,500 | |||||
Convertible notes, interest rate | 10% | |||||
Percentage increase in amount payable on default | 15% | |||||
Percentage increase in amount payable, second scenario | 10% | |||||
Percentage increase in amount payable, third default scenario | 5% | |||||
Conversion price per share | $ 10 | |||||
Number of days of notice to be given for conversion of notes into common stock | 5 days | |||||
Shares reserved | 6 | |||||
Debt instrument lock in period | 6 months | |||||
Number of days of notice to be given for redemption | 3 days | |||||
Debt instrument prepayment percentage premium | 15% | |||||
Number of days of notice to be given for prepayment | 15 days | |||||
Debt proceeds requiring investor consent | $ 50,000 | |||||
Additional debt, increase in interest rate | 5% | |||||
Amortization of issuance discount and costs | 314 | |||||
Net carrying value of note | 12,363 | 12,363 | $ 11,906 | |||
Loss on induced conversion | $ 18,800 | |||||
Debt instrument, decrease in debt per month | $ 7,500 | |||||
Debt instrument term of reduced outstanding amount | 5 months | |||||
Conversion of preferred stock to common stock (in shares) | 25.3 | |||||
Long-term Convertible Note - April 2, 2021 Note | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Convertible notes, interest rate | 22% | |||||
November Partitioned Notes | ||||||
Debt Instrument [Line Items] | ||||||
Convertible note, aggregate principal | $ 500 | $ 500 | ||||
Conversion of preferred stock to common stock (in shares) | 1.8 | |||||
Partitioned Notes Of April 2021 Notes [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Convertible note, aggregate principal | $ 9,800 | $ 18,700 |
Convertible Instruments and A_7
Convertible Instruments and Accrued Interest - Long-term Convertible Note - April 23, 2021 Note (Detail) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 6 Months Ended | |||
Apr. 23, 2021 | Nov. 30, 2022 | Aug. 31, 2022 | May 31, 2021 | |
Debt Instrument [Line Items] | ||||
Debt issuance costs | $ 2,100 | |||
Amortization of issuance discount and costs | 1,190 | |||
Net carrying value of note | $ 45,210 | $ 42,215 | ||
Warrants to purchase common shares, shares | 5.5 | |||
Indemnitors | ||||
Debt Instrument [Line Items] | ||||
Warrants to purchase common shares, shares | 45 | |||
Long-term Convertible Note - April 23, 2021 Note | ||||
Debt Instrument [Line Items] | ||||
Debt instrument term | 2 years | |||
Convertible note, aggregate principal | $ 28,500 | |||
Net Proceeds | 25,000 | |||
Unamortized discount | 3,400 | |||
Debt issuance costs | $ 100 | |||
Convertible notes, interest rate | 10% | |||
Percentage increase in amount payable on default | 15% | |||
Percentage increase in amount payable, second scenario | 10% | |||
Percentage increase in amount payable, third default scenario | 5% | |||
Conversion price per share | $ 10 | |||
Number of days of notice to be given for conversion of notes into common stock | 5 days | |||
Shares reserved | 6 | |||
Debt instrument lock in period | 6 months | |||
Number of days of notice to be given for redemption | 3 days | |||
Threshold trading days to satisfy redemption obligation | 3 days | |||
Debt instrument prepayment percentage premium | 15% | |||
Number of days of notice to be given for prepayment | 15 days | |||
Debt proceeds requiring investor consent | $ 75,000 | |||
Additional debt, increase in interest rate | 5% | |||
Amortization of issuance discount and costs | $ 876 | |||
Net carrying value of note | $ 32,847 | $ 30,309 | ||
Maximum | Long-term Convertible Note - April 23, 2021 Note | ||||
Debt Instrument [Line Items] | ||||
Conversion of principal and interest of convertible notes to common stock | $ 7,000 | |||
Convertible notes, interest rate | 22% |
Equity Awards and Warrants - Ac
Equity Awards and Warrants - Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Aug. 31, 2022 | Aug. 31, 2021 | Nov. 30, 2022 | May 31, 2022 | |
Liability Classified Warrants | ||||
Derivative liability (beginning balance) | ||||
Classified as liability due to lack of shares availability at issuance | 14,522 | |||
Classified as equity upon increase in availability | (23,123) | |||
Loss on derivative due to change in fair market value | 8,601 | $ 8,600 | ||
Derivative liability (ending balance) | ||||
Stock option and warrant activity | ||||
Options and warrants outstanding, Number of Shares | 90,705 | 90,705 | ||
Granted, Number of Shares | 116,439 | |||
Exercised, Number of Shares | (2,097) | |||
Forfeited/expired/cancelled, Number of Shares | (2,147) | |||
Options and warrants outstanding, Number of Shares | 202,900 | 90,705 | ||
Options and warrants outstanding and exercisable, Number of Shares | 189,085 | |||
Options and warrants outstanding, Weighted Average Exercise Price | $ 0.77 | $ 0.77 | ||
Granted, Weighted Average Exercise Price | 0.29 | |||
Exercised, Weighted Average Exercise Price | 0.79 | |||
Forfeited/expired/cancelled, Weighted Average Exercise Price | 1.49 | |||
Options and warrants outstanding, Weighted Average Exercise Price | 0.48 | $ 0.77 | ||
Options and warrants outstanding and exercisable, Weighted Average Exercise Price | $ 0.47 | |||
Options and warrants outstanding, Weighted Average Remaining Contractual Life in Years | 4 years 9 months 18 days | 4 years 21 days | ||
Options and warrants outstanding and exercisable, Weighted Average Remaining Contractual Life in Years | 4 years 5 months 23 days | |||
Options and warrants outstanding, Aggregate Intrinsic Value | $ 9,616 | $ 352 | ||
Options and warrants outstanding and exercisable, Aggregate Intrinsic Value | 9,540 | |||
Loss on derivatives | $ 8,601 |
Equity Awards and Warrants - As
Equity Awards and Warrants - Assumptions used in Estimating Fair Value (Details) - Level 3 Inputs | Nov. 30, 2022 $ / shares | Aug. 31, 2022 $ / shares |
Grant Date Fair Value | Placement Agent Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.44 | 0.52 |
Grant Date Fair Value | Back Stop Warrant #1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.44 | 0.52 |
Grant Date Fair Value | Back Stop Warrant #2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.42 | 0.52 |
Risk free rate | Placement Agent Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.0313 | 0.0316 |
Risk free rate | Back Stop Warrant #1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.0317 | 0.0334 |
Risk free rate | Back Stop Warrant #2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.0306 | 0.0331 |
Expected term (in years) | Placement Agent Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 10 | 9.82 |
Expected term (in years) | Back Stop Warrant #1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 4.65 | 4.46 |
Expected term (in years) | Back Stop Warrant #2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 5 | 4.88 |
Stock price volatility | Placement Agent Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0.9599 | 0.9587 |
Stock price volatility | Back Stop Warrant #1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 1.1020 | 1.1729 |
Stock price volatility | Back Stop Warrant #2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 1.0949 | 1.1359 |
Expected dividend yield | Placement Agent Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0 | 0 |
Expected dividend yield | Back Stop Warrant #1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0 | 0 |
Expected dividend yield | Back Stop Warrant #2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative Liability, Measurement Input | 0 | 0 |
Equity Awards and Warrants - Op
Equity Awards and Warrants - Options, RSUs, PSUs (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Aug. 31, 2022 shares | Nov. 30, 2022 plan shares | Nov. 30, 2021 shares | May 31, 2022 shares | Aug. 30, 2021 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock, shares authorized | 1,350,000,000 | 1,350,000,000 | 1,350,000,000 | 1,000,000,000 | |
Number of active plans | plan | 1 | ||||
Number of inactive plans | plan | 1 | ||||
Tranche One [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vested, Shares | 10,900,000 | ||||
Award vesting period | 4 years | ||||
Tranche Two [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vested, Shares | 1,100,000 | ||||
Award vesting period | 1 year | ||||
Tranche Three | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option vested, Shares | 400,000 | ||||
Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option granted, Shares | 12,400,000 | 11,000,000 | |||
Award vesting period | 3 years | ||||
2012 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares authorized for issuance | 34,300,000 | ||||
Increase in number of shares authorized | 350 | ||||
Shares reallocated to be used for general purposes | 22,000,000 | ||||
Percentage of share outstanding | 1% | ||||
Shares available for future stock-based grants | 3,900,000 | ||||
2012 Equity Incentive Plan | Management, Employees And Consultants | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for future stock-based grants | 22,000,000 |
Equity Awards and Warrants - Re
Equity Awards and Warrants - Restricted Stock Units ("RSUs") and Performance Stock Units ("PSU"s) (Details) $ / shares in Units, shares in Thousands, $ in Millions | 6 Months Ended |
Nov. 30, 2022 USD ($) $ / shares shares | |
RSU and PSU | |
Number of shares | |
Beginning shares | shares | 300 |
Granted (in shares) | shares | 1,293 |
Forfeited (in shares) | shares | (67) |
Vested (in shares) | shares | (150) |
Ending shares | shares | 1,376 |
Weighted average grant date fair value | |
Beginning | $ / shares | $ 3.12 |
Grant | $ / shares | 0.58 |
Vested | $ / shares | 3.12 |
Forfeited | $ / shares | 3.12 |
Ending | $ / shares | $ 0.73 |
Performance target level percentage for non-vested equity-based payment instruments | 100% |
Performance Shares [Member] | |
Weighted average grant date fair value | |
Unrecognized compensation expense | $ | $ 0.6 |
Expected to be recognized over weighted-average period | 2 years 7 months 6 days |
Performance Shares [Member] | Maximum | |
Weighted average grant date fair value | |
Performance target level percentage for non-vested equity-based payment instruments | 100% |
Performance Shares [Member] | Minimum | |
Weighted average grant date fair value | |
Performance target level percentage for non-vested equity-based payment instruments | 0% |
Equity Awards and Warrants - Ex
Equity Awards and Warrants - Expense and unrecognized (Details) - USD ($) shares in Millions, $ in Millions | 3 Months Ended | 6 Months Ended | |||
Nov. 30, 2022 | Nov. 30, 2021 | Nov. 30, 2022 | Nov. 30, 2021 | Aug. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock warrants to purchase shares | 5.5 | ||||
General and Administrative Expenses | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock based compensation | $ 1.8 | $ 2.1 | $ 3.1 | $ 4.7 |
Equity Awards and Warrants - Pr
Equity Awards and Warrants - Private Placement of Shares of Common Stock and Warrants (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||
Aug. 31, 2022 | Aug. 30, 2022 | Feb. 14, 2022 | Nov. 30, 2022 | Aug. 31, 2022 | Jun. 30, 2022 | Nov. 30, 2021 | [1] | Aug. 31, 2021 | [1] | Nov. 30, 2022 | Nov. 30, 2021 | [1] | May 31, 2022 | Jan. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.255 | $ 0.40 | $ 0.255 | ||||||||||||
Warrant exercises (in shares) | 500,000 | ||||||||||||||
Exercise of warrants for cash | $ 300,000 | ||||||||||||||
Cashless exercise of warrants, shares | 200,000 | ||||||||||||||
Cashless exercise of warrants, warrants | 300,000 | ||||||||||||||
Shares issued during the period new issues shares | 4,600,000 | ||||||||||||||
Change of fair value of liability-classified equity instrument upon reclassification | $ 8,601,000 | ||||||||||||||
Common stock warrants to purchase shares | 5,500,000 | 5,500,000 | |||||||||||||
Warrant covering common stock shares purchased, percentage | 75% | 50% | |||||||||||||
Placement agent fees and expenses | $ 2,800,000 | ||||||||||||||
Incremental fair value of warrants | $ 4,200,000 | ||||||||||||||
Warrants to purchase common shares, shares | 5,500,000 | 5,500,000 | |||||||||||||
Number of warrants expiration extended | 3,800,000 | ||||||||||||||
Proceeds from warrant exercises | $ 264,000 | $ 1,036,000 | |||||||||||||
Deemed dividends | $ 500,000 | ||||||||||||||
CytoDyn Inc. | David F Welch | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Ownership percentage | 5% | 5% | |||||||||||||
Back Stop Warrant #1 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.10 | $ 0.10 | |||||||||||||
Common stock warrants to purchase shares | 7,500,000 | 7,500,000 | |||||||||||||
Warrants to purchase common shares, shares | 7,500,000 | 7,500,000 | |||||||||||||
Back Stop Warrant #2 | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.10 | $ 0.10 | |||||||||||||
Common stock warrants to purchase shares | 7,500,000 | 7,500,000 | |||||||||||||
Warrants to purchase common shares, shares | 7,500,000 | 7,500,000 | |||||||||||||
Former CEO | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Compensation policy period | 18 months | ||||||||||||||
Shares issued during the period new issues shares | 380,704 | ||||||||||||||
Former General Counsel | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Compensation policy period | 12 months | ||||||||||||||
Shares issued during the period new issues shares | 79,391 | ||||||||||||||
Private Equity Offering | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Stock issued for private offerings | $ 17,544,000 | $ 27,307,000 | $ 2,872,000 | ||||||||||||
Accredited Investors | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Shares issued during the period new issues shares | 85,400,000 | ||||||||||||||
Stock issued for private offerings | $ 18,900,000 | ||||||||||||||
Proceeds, net of issuance costs | $ 7,700,000 | ||||||||||||||
Private Warrant Exchange [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 1 | $ 1 | |||||||||||||
Placement agent fees and expenses | $ 2,100,000 | ||||||||||||||
Exercise of warrants, net of offering costs (in shares) | 9,700,000 | ||||||||||||||
Shares issued on warrant inducement | 8,400,000 | ||||||||||||||
Proceeds from warrant exercises | $ 2,100,000 | ||||||||||||||
Deemed dividends | 500,000 | ||||||||||||||
Allotment to placement agent | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.40 | $ 0.255 | |||||||||||||
Common stock warrants to purchase shares | 19,400,000 | ||||||||||||||
Term of warrants | 10 years | ||||||||||||||
Warrant covering common stock shares purchased, percentage | 13% | ||||||||||||||
Placement agent fees and expenses | $ 50,000 | ||||||||||||||
Warrants to purchase common shares, shares | 19,400,000 | ||||||||||||||
Second Private Placement | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.306 | ||||||||||||||
Exercise price of stock warrant combo, per share | $ 0.255 | ||||||||||||||
Shares issued during the period new issues shares | 34,600,000 | ||||||||||||||
Common stock warrants to purchase shares | 64,000,000 | ||||||||||||||
Term of warrants | 5 years | ||||||||||||||
Number of common shares in a fixed combination issue of shares | 1 | ||||||||||||||
Number Of Warrants In Fixed Combination Issue Of Securities | 1 | ||||||||||||||
Warrant exercise price percentage of final unit price | 120% | ||||||||||||||
Warrants to purchase common shares, shares | 64,000,000 | ||||||||||||||
Surety Bond Backstop Agreement | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Interest rate | 10% | ||||||||||||||
Period of Indemnification, Payment by Indemnitors | 90 days | ||||||||||||||
Indemnification Fee Payment Ratio | 1.50% | ||||||||||||||
Amount of cash collateral to be relieved of amount currently pledged | 1,000,000 | $ 1,000,000 | $ 1,500,000 | ||||||||||||
Amount of cash collateral to be relieved of amount currently pledged by Indemnity in support of Surety Bond | $ (5,000,000) | $ (5,000,000) | |||||||||||||
Surety Bond Backstop Agreement | Four Good Warrants | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.10 | $ 0.10 | |||||||||||||
Term of warrants | 5 years | 5 years | |||||||||||||
Initial Warrant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Common stock warrants to purchase shares | 15,000,000 | ||||||||||||||
Warrants to purchase common shares, shares | 15,000,000 | ||||||||||||||
Make-Whole Warrant | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Common stock warrants to purchase shares | 15,000,000 | ||||||||||||||
Warrants to purchase common shares, shares | 15,000,000 | ||||||||||||||
Four Good Warrants | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Change of fair value of liability-classified equity instrument upon reclassification | $ 6,600,000 | ||||||||||||||
Maximum | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.75 | $ 0.75 | |||||||||||||
Warrant covering common stock shares purchased, percentage | 0.50% | ||||||||||||||
Maximum | Allotment to placement agent | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | $ 0.306 | $ 0.306 | |||||||||||||
Minimum | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Exercise price of warrants, per share | 0.45 | $ 0.45 | |||||||||||||
Cashless exercise of warrants, exercise price | $ 0.26 | $ 0.26 | |||||||||||||
Minimum | Surety Bond Backstop Agreement | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||
Amount of cash collateral to be relieved of amount currently pledged | $ 1,500,000 | $ 1,500,000 | |||||||||||||
[1] See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |
Equity Awards and Warrants - St
Equity Awards and Warrants - Stock Options and Other Equity Awards (Details) - $ / shares | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Apr. 30, 2022 | Aug. 31, 2022 | Nov. 30, 2021 | Aug. 31, 2021 | Nov. 30, 2022 | Nov. 30, 2021 | May 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options grant date fair value | $ 0.34 | $ 1.11 | |||||
Warrant exercises (in shares) | 500,000 | ||||||
Shares issued during the period new issues shares | 4,600,000 | ||||||
Common Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Warrant exercises (in shares) | 657,000 | 963,000 | 668,000 | ||||
Executives | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percent of salary in lieu of cash, net of payroll deductions and withholding taxes | 25% | ||||||
Shares issued | 522,382 | ||||||
Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock option granted, Shares | 12,400,000 | 11,000,000 | |||||
Award vesting period | 3 years |
Loss Per Common Share - Summary
Loss Per Common Share - Summary of Reconciliation of Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Nov. 30, 2022 | Aug. 31, 2022 | Nov. 30, 2021 | [1] | Aug. 31, 2021 | [2] | Nov. 30, 2022 | Nov. 30, 2021 | [1] | |
Loss Per Common Share | |||||||||
Net loss | $ (26,495) | $ (20,991) | $ (40,077) | [2] | $ (45,337) | $ (47,486) | $ (85,414) | [2] | |
Less: Deemed dividends | (1,140) | (5,294) | |||||||
Less: Accrued preferred stock dividends | (370) | (417) | (756) | (842) | |||||
Net loss applicable to common stockholders | $ (28,005) | $ (40,494) | $ (53,536) | $ (86,256) | |||||
Weighted average common shares outstanding, Basic | 813,373 | 662,600 | [2] | 800,545 | 647,517 | [2] | |||
Weighted average common shares outstanding, Diluted | 813,373 | 662,600 | 800,545 | 647,517 | |||||
Loss per share, Basic | $ (0.03) | $ (0.06) | [2] | $ (0.07) | $ (0.13) | [2] | |||
Loss per share, Diluted | $ (0.03) | $ (0.06) | $ (0.07) | $ (0.13) | |||||
[1] See Note 2, Summary of Significant Accounting Policies See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |
Loss Per Common Share - Summa_2
Loss Per Common Share - Summary of Weighted Average Number of Shares of Common Stock Outstanding (Details) - shares shares in Thousands | 6 Months Ended | |
Nov. 30, 2022 | Nov. 30, 2021 | |
Stock options, warrants & unvested restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Antidilutive securities excluded from computation of loss per common share | 204,273 | 73,223 |
Convertible notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Antidilutive securities excluded from computation of loss per common share | 12,000 | 12,000 |
Convertible Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Antidilutive securities excluded from computation of loss per common share | 32,591 | 34,089 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Nov. 30, 2022 | Nov. 30, 2021 | [1] | Nov. 30, 2022 | Nov. 30, 2021 | [1] | May 31, 2022 | |
Income Taxes | |||||||
Income tax expense | $ 0 | $ 0 | $ 0 | $ 0 | |||
Effective Income Tax Rate Reconciliation Percent | |||||||
Income tax provision at statutory rate | 21% | 21% | |||||
Effective income tax rate | 0% | 0% | |||||
[1] See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |
Commitments and Contingencies_2
Commitments and Contingencies (Details) $ in Thousands | 6 Months Ended | ||||
Dec. 20, 2022 item | Jun. 04, 2021 lawsuit | Nov. 30, 2022 USD ($) | Jan. 31, 2022 USD ($) | Jan. 06, 2022 USD ($) | |
Shareholder Derivative Lawsuits | |||||
Commitments and Contingencies | |||||
Consolidated number of lawsuits | lawsuit | 3 | ||||
Securities and Exchange Commission and Department of Justice Investigations | Mr. Pourhassan | |||||
Commitments and Contingencies | |||||
Number of conspiracy charges | 1 | ||||
Number of security fraud charges | 4 | ||||
Number of wire fraud charges | 3 | ||||
Number of insider trading charges | 3 | ||||
Securities and Exchange Commission and Department of Justice Investigations | Kazem Kazempour | |||||
Commitments and Contingencies | |||||
Number of conspiracy charges | 1 | ||||
Number of security fraud charges | 3 | ||||
Number of wire fraud charges | 2 | ||||
Number of insider trading charges | 1 | ||||
Samsung BioLogics Co., Ltd. ("Samsung") | |||||
Commitments and Contingencies | |||||
Forecast period | 3 years | ||||
Amount of material breach of' Master Services and Project Specific Agreements | $ | $ 13,500 | ||||
Additional Contractual Obligation | $ | $ 22,800 | ||||
Past due balance | $ | $ 232,788 | ||||
Accounts Payable | Samsung BioLogics Co., Ltd. ("Samsung") | |||||
Commitments and Contingencies | |||||
Past due balance | $ | $ 35,000 |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Future Commitments (Details) - Samsung BioLogics Co., Ltd. ("Samsung") $ in Thousands | Nov. 30, 2022 USD ($) |
Fiscal Year | |
2023 (6 months remaining) | $ 34,638 |
2024 | 121,750 |
2025 | 76,400 |
Total | $ 232,788 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Operating Lease Balances (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Nov. 30, 2022 | Nov. 30, 2021 | Nov. 30, 2022 | Nov. 30, 2021 | May 31, 2022 | |
Commitments and Contingencies. | |||||
Operating lease costs | $ 46,400 | $ 48,900 | $ 100,000 | $ 100,000 | |
Right of use asset | $ 468,000 | $ 468,000 | $ 536,000 | ||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other Assets, Noncurrent | Other Assets, Noncurrent | Other Assets, Noncurrent | ||
Current operating lease liability | $ 136,000 | $ 136,000 | $ 134,000 | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Compensation And Non-financing Liabilities | Accrued Compensation And Non-financing Liabilities | Accrued Compensation And Non-financing Liabilities | ||
Non-current operating lease liability | $ 353,000 | $ 353,000 | $ 422,000 | ||
Total operating lease liability | $ 489,000 | $ 489,000 | $ 556,000 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Minimum (Base Rental) Lease Payments (Details) - USD ($) $ in Thousands | Nov. 30, 2022 | May 31, 2022 |
Fiscal Year | ||
2023 (6 months remaining) | $ 89 | |
2024 | 182 | |
2025 | 185 | |
2026 | 169 | |
Total operating lease payments | 625 | |
Less: imputed interest | (136) | |
Present value of operating lease liabilities | $ 489 | $ 556 |
Commitments and Contingencies_5
Commitments and Contingencies - Supplemental Information Related to Operating Leases (Details) | Nov. 30, 2022 |
Commitments and Contingencies. | |
Weighted average remaining lease term | 3 years 4 months 24 days |
Weighted average discount rate | 10% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | ||||||
Apr. 02, 2021 | Jan. 31, 2023 | Dec. 31, 2022 | Nov. 30, 2022 | Nov. 30, 2021 | [1] | Aug. 31, 2022 | Aug. 30, 2022 | |
Subsequent Event [Line Items] | ||||||||
Class of warrants, exercise price | $ 0.255 | $ 0.40 | ||||||
Warrant exercises (in shares) | 500,000 | |||||||
Proceeds from warrant exercises | $ 264 | $ 1,036 | ||||||
April 2, 2021 Note | ||||||||
Subsequent Event [Line Items] | ||||||||
Convertible note, aggregate principal | $ 28,500 | $ 9,300 | ||||||
Conversion of preferred stock to common stock (in shares) | 25,300,000 | |||||||
Minimum | ||||||||
Subsequent Event [Line Items] | ||||||||
Class of warrants, exercise price | $ 0.45 | |||||||
Maximum | ||||||||
Subsequent Event [Line Items] | ||||||||
Class of warrants, exercise price | $ 0.75 | |||||||
Warrant exchange agreement | ||||||||
Subsequent Event [Line Items] | ||||||||
Restricted cash | $ 200 | |||||||
Subsequent Event | April 2, 2021 Note | ||||||||
Subsequent Event [Line Items] | ||||||||
Convertible note, aggregate principal | $ 8,300 | |||||||
Subsequent Event | December partitioned notes | ||||||||
Subsequent Event [Line Items] | ||||||||
Convertible note, aggregate principal | $ 1,000 | |||||||
Conversion of preferred stock to common stock (in shares) | 4,700,000 | |||||||
Subsequent Event | Warrant exchange agreement | Accredited investors warrants | ||||||||
Subsequent Event [Line Items] | ||||||||
Warrant exercises (in shares) | 3,400,000 | |||||||
Shares issued on warrant inducement | 600,000 | |||||||
Proceeds from warrant exercises | $ 700 | |||||||
Subsequent Event | Warrant exchange agreement | Accredited investors warrants | Minimum | ||||||||
Subsequent Event [Line Items] | ||||||||
Class of warrants, exercise price | $ 0.50 | |||||||
Subsequent Event | Warrant exchange agreement | Accredited investors warrants | Maximum | ||||||||
Subsequent Event [Line Items] | ||||||||
Class of warrants, exercise price | $ 0.75 | |||||||
Subsequent Event | January offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Offering costs for stock issuance | $ 15,000 | |||||||
Number of shares per unit | 1 | |||||||
Number of warrants per unit | 1 | |||||||
Number of shares per warrant | 1 | |||||||
[1] See Note 2, Summary of Significant Accounting Policies — Revision and Restatement of Financial Statements . |