CytoDyn Inc
For the period ended Nov 30, 2023. Filed Jan 16, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Nov 30, 2023 · Filed Jan 16, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
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ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Balance Sheets
(Unaudited, in thousands, except par value)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · · November 30, 2023 · · May 31, 2023 | ||||||
| Assets · · · · · | ||||||
| Current assets: · · · | ||||||
| Cash | | $147 | | $2,541 | ||
| Restricted cash | | 6,577 | | 6,507 | ||
| Prepaid expenses | | 1,578 | | 1,167 | ||
| Prepaid service fees | | 538 | | 590 | ||
| Total current assets | | 8,840 | | 10,805 | ||
| Other non-current assets | | 400 | | 487 | ||
| Total assets | | $9,240 | | $11,292 | ||
| Liabilities and Stockholders’ Deficit | | | ||||
| Current liabilities: | | | ||||
| Accounts payable | | $62,328 | | $62,725 | ||
| Accrued liabilities and compensation | | 9,150 | | 6,669 | ||
| Accrued interest on convertible notes | | 12,936 | | 10,598 | ||
| Accrued dividends on convertible preferred stock | | 6,049 | | 5,308 | ||
| Convertible notes payable, net | | 32,914 | | 34,417 | ||
| Derivative liability - equity instruments | | | 33 | | | 79 |
| Total current liabilities | | 123,410 | | 119,796 | ||
| Notes payable, net | | | — | | | 714 |
| Operating leases | | 211 | | 283 | ||
| Total liabilities | | 123,621 | | 120,793 | ||
| Commitments and Contingencies (Note 8) | | | ||||
| Stockholders’ deficit: | | | ||||
| Preferred stock, $0.001 par value; 5,000 shares authorized: | | | ||||
| Series B convertible preferred stock, $0.001 par value; 400 authorized; 19 issued and outstanding at November 30, 2023 and May 31, 2023 | | — | | — | ||
| Series C convertible preferred stock, $0.001 par value; 8 authorized; 6 issued and outstanding at November 30, 2023 and May 31, 2023 | | — | | — | ||
| Series D convertible preferred stock, $0.001 par value; 12 authorized; 9 issued and outstanding at November 30, 2023 and May 31, 2023 | | — | | — | ||
| Common stock, $0.001 par value; 1,750,000 shares authorized; 971,729 and 919,053 issued, and 971,286 and 918,610 outstanding at November 30, 2023 and May 31, 2023, respectively | | 971 | | 919 | ||
| Treasury stock, $0.001 par value; 443 shares at November 30, 2023 and May 31, 2023 | | | — | | | — |
| Additional paid-in capital | | 747,472 | | 731,270 | ||
| Accumulated deficit | | (862,824) | | (841,690) | ||
| Total stockholders’ deficit | | (114,381) | | (109,501) | ||
| Total liabilities and stockholders' deficit | | $9,240 | | $11,292 | ||
Consolidated Statements of Operations
(Unaudited, in thousands, except per share data)
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended November 30, · · Six months ended November 30, · | |||||||||||||
| · 2023 · 2022 · 2023 · 2022 · | |||||||||||||
| Operating expenses: · · · · | |||||||||||||
| General and administrative | | $2,311 | | $5,043 | | $4,999 | | $11,376 | | ||||
| Research and development | | 1,079 | | 137 | | 2,993 | | 713 | | ||||
| Amortization and depreciation | | 8 | | 54 | | 18 | | 153 | | ||||
| Inventory charge | | | — | | | 17,929 | | | — | | | 20,633 | |
| Total operating expenses | | 3,398 | | 23,163 | | 8,010 | | 32,875 | | ||||
| Operating loss | | (3,398) | | (23,163) | | (8,010) | | (32,875) | | ||||
| Interest and other expenses: | | | | | | | | | | | | | |
| Interest on convertible notes | | (1,164) | | (1,159) | | (2,361) | | (2,305) | | ||||
| Amortization of discount on convertible notes | | | (142) | | | (580) | | | (542) | | | (1,156) | |
| Amortization of debt issuance costs | | (3) | | (18) | | (369) | | (34) | | ||||
| Issuance costs for private placement of shares and warrants through placement agent (Note 5) | | | (906) | | | — | | | (906) | | | — | |
| Loss on induced conversion | | (636) | | | (638) | | | (2,640) | | | (638) | | |
| Finance charges | | (891) | | (937) | | (1,803) | | (1,877) | | ||||
| Loss on note extinguishment | | (2,406) | | — | | (4,490) | | — | | ||||
| Gain (loss) on derivatives | | | (17) | | | — | | | (13) | | | (8,601) | |
| Total interest and other expenses | | (6,165) | | (3,332) | | (13,124) | | (14,611) | | ||||
| Loss before income taxes | | (9,563) | | (26,495) | | (21,134) | | (47,486) | | ||||
| Income tax benefit | | — | | — | | — | | — | | ||||
| Net loss | | $(9,563) | | $(26,495) | | $(21,134) | | $(47,486) | | ||||
| Basic and diluted: | | | | | | | | | | | | | |
| Weighted average common shares outstanding | | | 958,988 | | | 813,373 | | | 941,191 | | | 800,545 | |
| Loss per share | | $(0.01) | | $(0.03) | | $(0.02) | | $(0.07) | | ||||
Consolidated Statement of Changes in Stockholders’ Deficit
(Unaudited, in thousands)
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Preferred stock · · Common stock · · Treasury stock · Additional · Accumulated · Total stockholders' | ||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · · paid-in capital · · deficit · · deficit | ||||||||||||||||||||||||
| Balance at May 31, 2023 | | 34 | | $— | | 919,053 | | $919 | | 443 | | $— | | $731,270 | | $(841,690) | | $(109,501) | ||||||
| Issuance of stock for convertible note repayment | | — | | | — | | 8,661 | | | 8 | | — | | | — | | 1,492 | | — | | 1,500 | |||
| Loss on induced conversion | | — | | | — | | — | | | — | | — | | | — | | 2,004 | | — | | 2,004 | |||
| Warrants issued in note offering | | — | | | — | | — | | | — | | — | | | — | | 170 | | — | | 170 | |||
| Stock issued for compensation | | — | | | — | | 686 | | | 1 | | — | | | — | | 154 | | — | | 155 | |||
| Warrant exercises | | — | | | — | | 3,000 | | | 3 | | — | | | — | | 297 | | — | | 300 | |||
| Dividends accrued on Series C and D convertible preferred stock | | — | | | — | | — | | | — | | — | | | — | | (373) | | — | | (373) | |||
| Reclassification of warrants from liability to equity classified | | — | | | — | | — | | | — | | — | | | — | | | 79 | | | — | | | 79 |
| Stock-based compensation | | — | | | — | | — | | | — | | — | | | — | | 348 | | — | | 348 | |||
| Net loss | | — | | | — | | — | | | — | | — | | | — | | — | | (11,571) | | (11,571) | |||
| Balance at August 31, 2023 | | 34 | | | — | | 931,400 | | | 931 | | 443 | | | — | | | 735,441 | | | (853,261) | | | (116,889) |
| Issuance of stock for convertible note repayment | | — | | | — | | 3,535 | | | 4 | | — | | | — | | | 496 | | | — | | 500 | |
| Loss on induced conversion | | — | | | — | | — | | | — | | — | | | — | | | 636 | | | — | | | 636 |
| Warrants issued in note offering | | — | | | — | | — | | | — | | — | | | — | | | 10 | | | — | | | 10 |
| Note conversion | | — | | | — | | 14,339 | | | 14 | | — | | | — | | | 4,379 | | | — | | | 4,393 |
| Stock issued for compensation | | — | | | — | | 559 | | | 1 | | — | | | — | | | 97 | | | — | | | 98 |
| Stock issued for private offering | | — | | | — | | 21,453 | | | 21 | | — | | | — | | | 6,307 | | | — | | 6,328 | |
| Dividends accrued on Series C and D convertible preferred stock | | — | | | — | | — | | | — | | — | | | — | | | (368) | | | — | | (368) | |
| Stock-based compensation | | — | | | — | | — | | | — | | — | | | — | | | 474 | | | — | | 474 | |
| Net loss | | — | | | — | | — | | | — | | — | | | — | | | — | | | (9,563) | | (9,563) | |
| Balance at November 30, 2023 | | 34 | | $— | | 971,286 | | $971 | | 443 | | $— | | $747,472 | | $(862,824) | | $(114,381) | ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Preferred stock · · Common stock · · Treasury stock · Additional · Accumulated · Total stockholders' | ||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · · paid-in capital · · deficit · · deficit | ||||||||||||||||||||||||
| Balance at May 31, 2022 | | 35 | | $— | | 720,028 | | $720 | | 443 | | $— | | $671,013 | | $(766,131) | | $(94,398) | ||||||
| Stock issued for compensation | | — | | | — | | 879 | | | 1 | | — | | | — | | 344 | | — | | 345 | |||
| Stock issued for private offerings | | — | | | — | | 85,378 | | | 85 | | — | | | — | | 17,459 | | — | | 17,544 | |||
| Issuance costs related to stock issued for private offerings | | — | | | — | | — | | | — | | — | | | — | | (6,289) | | — | | (6,289) | |||
| Conversion of Series C convertible preferred stock to common stock | | (1) | | | — | | 1,136 | | | 1 | | — | | | — | | (1) | | — | | — | |||
| Warrant exercises | | — | | | — | | 657 | | | 1 | | — | | | — | | 263 | | — | | 264 | |||
| Deemed dividend paid in common stock due to down round provision, recorded in additional paid-in capital | | — | | | — | | 4,620 | | | 5 | | — | | | — | | (5) | | — | | — | |||
| Accrued preferred stock dividends | | — | | | — | | — | | | — | | — | | | — | | (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) | |||
| Balance at August 31, 2022 | | 34 | | | — | | 812,698 | | | 813 | | 443 | | | — | | | 687,732 | | | (782,857) | | | (94,312) |
| Issuance of stock for convertible note repayment | | — | | — | | 1,822 | | 2 | | — | | — | | 498 | | — | | 500 | ||||||
| Loss on induced conversion | | — | | | — | | — | | | — | | — | | | — | | | 638 | | | — | | | 638 |
| Stock issued for compensation | | — | | — | | 765 | | — | | — | | — | | 310 | | — | | 310 | ||||||
| Exercise of warrants, net of issuance costs | | — | | — | | 9,652 | | 10 | | — | | — | | 2,123 | | — | | 2,133 | ||||||
| Make-whole shares related to private warrant exchange | | — | | — | | 23 | | — | | — | | — | | — | | — | | — | ||||||
| Dividend paid in common stock upon conversion of Series C convertible preferred stock ($0.50 per share) | | — | | | — | | 319 | | | — | | — | | | — | | | 159 | | | — | | | 159 |
| 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) | ||||||
| Balance at November 30, 2022 | | 34 | | $— | | 825,279 | | $825 | | 443 | | $— | | $692,558 | | $(809,352) | | $(115,969) | ||||||
Consolidated Statements of Cash Flows
(Unaudited, in thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Six months ended November 30, | ||||||
| | 2023 | 2022 | ||||
| | | | | | | |
| Cash flows from operating activities: · · · | ||||||
| Net loss | | $(21,134) | | $(47,486) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | | | ||||
| Amortization and depreciation | | 18 | | 153 | ||
| Amortization of debt issuance costs | | 369 | | 34 | ||
| Issuance costs for private placement of shares and warrants through placement agent | | | 906 | | | — |
| Amortization of discount on convertible notes | | 542 | | 1,156 | ||
| Loss on derivatives | | | 13 | | | 8,601 |
| Loss on induced conversion | | | 2,640 | | | 638 |
| Loss on note extinguishment | | 4,490 | | — | ||
| Inventory charge | | | — | | | 20,633 |
| Stock-based compensation | | 1,075 | | 3,118 | ||
| Changes in operating assets and liabilities: | | | | |||
| (Increase) decrease in prepaid expenses and other assets | | | (290) | | | (303) |
| (Decrease) increase in accounts payable and accrued expenses | | 4,374 | | (2,024) | ||
| Net cash used in operating activities | | (6,997) | | (15,480) | ||
| Cash flows from investing activities: | | | ||||
| Net cash Provided by/used in investing activities | | — | | — | ||
| Cash flows from financing activities: | | | ||||
| Proceeds from warrant transactions, net of offering costs | | | — | | | 2,133 |
| Proceeds from sale of common stock and warrants, net of issuance costs | | 3,016 | | 11,255 | ||
| Proceeds from warrant exercises | | 300 | | 264 | ||
| Proceeds held in trust | | — | | 200 | ||
| Proceeds from convertible note and warrant issuances, net of issuance costs | | | 1,357 | | | — |
| Net cash provided by financing activities | | 4,673 | | 13,852 | ||
| Net change in cash and restricted cash | | (2,324) | | (1,628) | ||
| Cash and restricted cash at beginning of period | | 9,048 | | 4,231 | ||
| Cash and restricted cash at end of period | | $6,724 | | $2,603 | ||
| Cash and restricted cash consisted of the following: | | | | | | |
| Cash | | $147 | | $2,403 | ||
| Restricted cash | | | 6,577 | | | 200 |
| Total cash and restricted cash | | $6,724 | | $2,603 | ||
| Supplemental disclosure: | | | | | | |
| Cash paid for interest | | $38 | | $— | ||
| Non-cash investing and financing transactions: | | | ||||
| Derivative liability associated with warrants | | $80 | | $8,601 | ||
| Issuance of common stock for principal of convertible notes | | $2,000 | | $500 | ||
| Accrued dividends on Series C and D convertible preferred stock | | $741 | | $753 | ||
| Warrants issued to placement agent | | $413 | | $159 | ||
| Deemed dividend on common stock issued due to down round provision, recorded in additional paid-in capital | | $— | | $5,294 | ||
| Note conversion to common stock and warrants | | $2,295 | | $— | ||
CYTODYN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
AS OF NOVEMBER 30, 2023
(Unaudited)
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, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (“CCR5”).
The Company has been investigating leronlimab as a viral entry inhibitor for treatment of human immunodeficiency virus (“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 Metabolic dysfunction-associated steatohepatitis (“MASH”), replacement for the term nonalcoholic steatohepatitis (“NASH”). Leronlimab is being or has been studied in MASH, MASH-HIV, solid tumors in oncology, and other HIV indications where CCR5 is believed to play an integral role.
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 subsidiary, CytoDyn Operations Inc. All intercompany transactions and balances are eliminated in consolidation. 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. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States(“U.S. GAAP” or “GAAP”)have been omitted in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”). 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, 2023 (the “2023 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 a material effect on the Company’s previously reported financial position, results of operations, stockholders’ deficit, or net cash provided by operating activities.
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 $21.1 million for the six months ended November 30, 2023, and has an accumulated deficit of approximately $862.8 million as of November 30, 2023. These factors, among several others, including the various matters discussed in Note 8,Commitments and Contingencies, raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
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 and a new or modified longer-acting therapeutic 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 U.S Food and Drug Administration’s (the “FDA”) clinical hold with regard to the Company’s HIV program, performing additional pre-clinical and clinical studies in various indications, 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 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 and write-off 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.
Restricted cash
As of November 30, 2023, the Company had recorded approximately $6.6 million of restricted cash. The restricted cash is related to cash held as collateral in connection with a surety bond that was posted as required in the Amarex litigation and will remain as restricted cash until the litigation is resolved.
Recent Accounting Pronouncements
In July 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU")2023-03,“Presentation of Financial Statements (Topic 205), Income Statement - Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation - Stock Compensation (Topic 718): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 - General Revision of Regulation S-X: Income or Loss Applicable to Common Stock” (“ASU 2023-03”). This ASU amends various paragraphs in the accounting codification pursuant to the issuance of Commission Staff Bulletin ("SAB") number 120. ASU 2023-03 does not provide any new guidance and is immediately effective. ASU 2023-03 did not have a material impact on the consolidated financial statements.
In October 2023, the FASB issued ASU 2023-06,Disclosure Improvements–*Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative.*The amendments clarify or improve disclosure and presentation requirements on various disclosure areas, including the statement of cash flows, earnings per share, debt, equity, and derivatives. The amendments will align the requirements in the FASB ASC with the SEC’s regulations. The amendments in this ASU will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC, and will not be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. The Company is currently evaluating the impact of the amendments on its financial statement disclosures.
On December 14, 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for annual periods beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.
Note 3. Accounts Payable and Accrued Liabilities and Compensation
As of November 30, 2023 and May 31, 2023, the accounts payable balance was approximately $62.3 million and $62.7 million, respectively, withtwo vendors accounting for 70% and 72% of the total balance of accounts payable at the respective dates.
The components of accrued liabilities and compensation are as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | | | November 30, 2023 | | | May 31, 2023 |
| Compensation and related expense | | $228 | | $335 | ||
| Legal fees and settlement | | | 81 | | | 168 |
| Clinical expense | | | 346 | | | 187 |
| Accrued inventory charges and expenses | | 7,023 | | 4,978 | ||
| License fees | | | 1,330 | | | 862 |
| Lease payable | | | 142 | | | 139 |
| Total accrued liabilities | | $9,150 | | $6,669 |
Note 4. 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, 2023 · · May 31, 2023 | ||||||||||||||||||
| (in thousands except conversion rate) · Series B · Series C · Series D · Series B · Series C · Series D | ||||||||||||||||||
| Shares of preferred stock outstanding | | | 19 | | | 6 | | | 9 | | | 19 | | | 6 | | | 9 |
| Common stock conversion rate | | | 10:1 | | | 2,000:1 | | | 1,250:1 | | | 10:1 | | | 2,000:1 | | | 1,250:1 |
| Total shares of common stock if converted | | | 190 | | | 12,670 | | | 10,565 | | | 190 | | | 12,670 | | | 10,565 |
| Undeclared dividends | | $17 | | $ | - | | $ | - | | $15 | | $ | - | | $ | - | ||
| Accrued dividends | | $ | - | | $2,818 | | $3,231 | | $ | - | | $2,500 | | $2,808 | ||||
| Total shares of common stock if dividends converted | | | 34 | | | 5,636 | | | 6,462 | | | 30 | | | 5,000 | | | 5,616 |
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 preferred stock provides for a liquidation preference over the common shares of $5.00 per share, plus any accrued and unpaid dividends. In the event of liquidation, holders of Series C and Series D preferred stock will be entitled to receive, on a pari passu basis, and in preference of any payment or distribution to holders of the Series B preferred stock and common stock, an amount per share equal to $1,000 per share plus any accrued and unpaid dividends.
Convertible notes and accrued interest
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · November 30, 2023 · · May 31, 2023 | ||||||||||||||||||||||||
| (in thousands) · April 2, 2021 Note · April 23, 2021 Note · Short-term Notes · · Total · April 2, 2021 Note · April 23, 2021 Note · · · Placement Agent Notes · · Total | ||||||||||||||||||||||||
| Convertible notes payable outstanding principal | | $4,081 | | $29,369 | | $250 | | $33,700 | | $6,081 | | $29,369 | | $1,000 | | $36,450 | ||||||||
| Less: Unamortized debt discount and issuance costs | | | (102) | | | (607) | | | (77) | | | (786) | | | (211) | | | (822) | | | (286) | | | (1,319) |
| Convertible notes payable, net | | | 3,979 | | | 28,762 | | | 173 | | | 32,914 | | | 5,870 | | | 28,547 | | | 714 | | | 35,131 |
| Accrued interest on convertible notes | | | 4,261 | | | 8,675 | | | - | | | 12,936 | | | 3,804 | | | 6,789 | | | 5 | | | 10,598 |
| Outstanding convertible notes payable, net and accrued interest | | $8,240 | | $37,437 | | $173 | | $45,850 | | $9,674 | | $35,336 | | $719 | | $45,729 | ||||||||
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 · · · Placement Agent Notes · · · Short-Term Notes · · Total | |||||||||||||||
| Outstanding balance at May 31, 2023 | | $9,674 | | $35,336 | | $719 | | $ | - | | $45,729 | ||||
| Consideration received | | | - | | | - | | | 975 | | | 169 | | | 1,144 |
| Amortization of issuance discount and costs | | | 109 | | | 215 | | | 583 | | | 4 | | | 911 |
| Interest expense | | | 457 | | | 1,886 | | | 18 | | | - | | | 2,361 |
| Fair market value of shares and warrants exchanged for repayment | | | (2,640) | | | - | | | (4,379) | | | - | | | (7,019) |
| Difference between market value ofcommon shares and reduction of principal | | | 640 | | | - | | | 2,084 | | | - | | | 2,724 |
| Outstanding balance at November 30, 2023 | | $8,240 | | $37,437 | | $ | - | | $173 | | $45,850 | ||||
April 2, 2021 & April 23, 2021 Notes
Key terms of the outstanding convertible notes are as follows:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · November 30, 2023 | ||||||||
| · April 2, 2021 Note · · April 23, 2021 Note · | ||||||||
| Interest rate per annum | | | 10% | | | 10% | ||
| Conversion price per share upon five trading days' notice | | $10.00 | | | $10.00 | | ||
| Party that controls the conversion rights | | | Investor | | | | Investor | |
| Maturity date | | | April 5, 2025 | | | | April 23, 2025 | |
| Security interest | | | All Company assets excluding intellectual property | | ||||
In addition to standard anti-dilution adjustments, the conversion price of the April 2, 2021 Note and April 23, 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 and April 23, 2021 Note provide for liquidated damages upon failure to deliver common stock within specified timeframes and require the Company to maintain a share reservation of 6.0 million shares of common stock for each Note.
During the six months ended November 30, 2023, in satisfaction of redemptions, the Company and the April 2, 2021 Noteholder entered into four exchange agreements, pursuant to which the April 2, 2021 Note was partitioned into new notes (the “Partitioned Notes”) with an aggregate principal amount of $2.0 million, which was exchanged concurrently with the issuance of approximately 12.2 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 $4.1 million. The Company accounted for the Partitioned Notes and exchange settlements as induced conversions, and, accordingly, recorded a non-cash loss on convertible debt induced conversion of $2.6 million for the six months ended November 30, 2023.
As of December 31, 2023, the holders of the April 2 and April 23 Notes waived all provisions in the convertible notes that, based on the occurrence of various events through that date, 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. Accordingly, the Company was not in default under the notes on December 31, 2023.
Please refer to Note 6,Convertible Instruments and Accrued Interest, in the Company’s 2023 Form 10-K for additional information.
Placement Agent Notes
During the period April through June 2023, the Company entered into securities purchase agreements pursuant to which the Company issued secured promissory notes bearing interest at a rate of 6.0% and with an 18-month term to accredited investors through a placement agent (“Placement Agent Notes”) for a total principal amount of$2.3 million, of which$1.3 million was sold in June 2023. The Placement Agent Notes were secured by the net cash recovery, if any, by the Company in its dispute with Amarex and provided the investors with a right to convert the unpaid principal and accrued but unpaid interest into shares of common stock upon the occurrence of an event of default. The Placement Agent Notes had maturity dates during the fiscal year ending May 31, 2025.
In connection with the sale in June 2023, the Company issued warrants to investors to purchase approximately 1.3 million shares of common stock with athree-year term and an exercise price of$0.50 per share. The net proceeds from the sale of the Placement Agent Notes in June of approximately$1.1 million reflect issuance costs of approximately$0.2 million. The Company also issued warrants to purchase approximately 0.4 million shares of common stock to the placement agent with aten-year term and an exercise price of$0.26 per share, which the Company accounted for as additional issuance costs related to the sale of Placement Agent Notes in June 2023. The Company allocated the proceeds between the liability-classified Placement Agent Notes and the equity-classified warrants based on their relative fair values.
During June 2023, an amendment was entered into with the investors of the Placement Agent Notes, which stated that the principal amount and accrued but unpaid interest on the notes would be converted into shares of common stock and warrants as of the first closing of a subsequent private placement of common stock and warrants through a placement agent. The deemed purchase price of a unit ofone share plusone warrant was fixed at 90% of the lower of the intraday volume weighted average price (“VWAP”) on the date of the first closing and last closing of the private placement, while the exercise price of the warrants was set at $0.306 per share, compared to $0.50 per share in the original private placement.
In July 2023, the first closing of the subsequent private placement of common stock and warrants through a placement agent occurred. Therefore, the Placement Agent Notes were converted into units with the same pricing as the private placement described in Note 5,Equity Awards and Warrants – Private placement of common stock and warrants through placement agent. The $2.1 million difference in fair value between the shares and warrants and the principal amount of the Placement Agent Notes was accounted for as a loss on note extinguishment. See Note 5,Equity Awards and Warrants – Liability-classified equity instruments for additional information.
Short-term Notes
During November 2023, the Company began issuing unsecured promissory notes bearing interest at a rate of 10% to accredited investors under a securities purchase agreement through a placement agent (“Short-term Notes”). Short-term Notes for a total principal amount of$0.3 million were issued in November 2023. The principal amount and accrued but unpaid interest on the notes will be converted into units consisting of shares of common stock and warrants as of the first closing of a subsequent private placement of common stock and warrants through a placement agent at a 20% discount to the price at which the units are sold in the private placement. The Short-term Notes’ maturity date is June 7, 2024. The Company also agreed to issue warrants at the final closing of the sale of Short-term Notes to purchaseone share of common stock for each dollar of principal amount of Short-term Notes sold. The warrants have afive-year term and an exercise price of$0.35 per share. The net proceeds from the sale of the Short-term Notes in November 2023 of$0.2 million reflect issuance costs of approximately$37.5 thousand. The Company allocated the proceeds between the liability-classified Short-term Notes and the equity-classified warrants based on their relative fair values.
The Company also agreed to issue warrants to purchase shares of common stock to the placement agent with a ten-year term, with the number of warrants and the exercise price of the warrants to be determined by the share price on the final closing date of the sale of Short-term Notes. The Company accounted for the warrants to be issued to the placement agent as additional issuance costs. See Note 5,Equity Awards and Warrants – Liability-classified equity instruments for additional information.
Note 5. Equity Awards and Warrants
Liability-classified equity instruments
During April and May 2023, the Company sold Placement Agent Notes through a placement agent. See Note 4,Convertible Instruments and Accrued Interest – Placement Agent Notes. The Company agreed to issue warrants to the placement agent as part of the issuance costs with an exercise price that was not determined until the final closing date. As the exercise price of the warrants was to be fixed based on the final terms of the offering, the Company accounted for the warrants as a liability-classified warrant beginning on the initial closing date until the final closing date. The value of the warrants at May 31, 2023, was recorded as a derivative liability on the balance sheet, and the change in the fair value of the warrants was recorded as a gain or loss on derivatives. On June 23, 2023, the final closing of the Placement Agent Notes occurred, and the fair value of the warrants became equity classified.
On July 31, 2023, the Placement Agent Notes were converted into units that had similar terms to units being offered in a private placement of shares and warrants through a placement agent. SeePrivate placement of common stock and warrants through placement agent below. As the unit price was not determinable until the final closing date of the subsequent private placement, the units related to the conversion of the Placement Agent Notes were recorded as a liability and at fair value. On October 23, 2023, the private placement was concluded, which finalized the unit purchase price at$0.16, and the fair value of the units became equity-classified.
During November 2023, in connection with the issuance of the Short-term Notes as described in Note 4,Convertible Instruments and Accrued Interest – Short-term Notes, the Company agreed to issue warrants to the placement agent as part of the issuance costs, with the ultimate number of warrants and exercise price to be determined as of the final closing date of a private placement of common stock and warrants through a placement agent that commenced in December 2023. As the number of warrants and the exercise price of the warrants will be variable until the final closing date, the Company accounted for the warrants as a liability-classified warrant beginning on the initial closing date until the final closing date. The value of the warrants was recorded as a derivative liability on the balance sheet, and the change in the fair value of the warrants is recorded as a gain or loss on derivatives.
In accordance with the prescribed accounting guidance, the Company measured fair value of liability-classified equity instruments using fair value hierarchy which include:
Level 1. Quoted prices in active markets for identical assets or liabilities.
| 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. |
The table below presents a reconciliation of the beginning and ending balances for liabilities measured at fair value as of May 31, 2023, and November 30, 2023:
| | | |
|---|---|---|
| (in thousands) · Derivative liability | ||
| Balance at May 31, 2023 | $79 | |
| Value upon notes converted to units in the private offering | 4,379 | |
| Warrants classified as equity during quarter | (79) | |
| Gain on derivative due to change in fair market value | (4) | |
| Balance at August 31, 2023 | $4,375 | |
| Value upon liability-classified equity instruments reclassified to equity | | (4,393) |
| Warrants classified as a liability during quarter | | 34 |
| Loss on derivative due to change in fair market value | | 17 |
| Balance at November 30, 2023 | $33 | |
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.
| | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · · · · · | ||||||||||||||
| · Placement · · Note conversion · Placement Agent · · Note conversion · · Note conversion · · Placement Agent · Placement Agent | ||||||||||||||
| | | Agent warrants | | warrants on | | warrants at | | warrants at | | warrants at | | warrants at | | warrants at |
| | | at May 31, 2023 | | conversion date | | equity classification | | August 31, 2023 | | equity classification | | issuance | | November 30, 2023 |
| Fair value of underlying stock | | $ 0.26 | | $ 0.21 | | $ 0.27 | | $ 0.21 | | $ 0.17 | | $ 0.18 | | $ 0.17 |
| Risk free rate | | 3.64% | | 4.18% | | 3.74% | | 4.23% | | 4.81% | | 4.42% | | 4.37% |
| Expected term (in years) | | 10.00 | | 5.00 | | 10.00 | | 5.00 | | 5.00 | | 10.00 | | 10.00 |
| Stock price volatility | | 97.90% | | 124.55% | | 97.45% | | 124.06% | | 124.70% | | 95.82% | | 95.82% |
| Expected dividend yield | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% |
Equity Incentive Plan (“EIP”)
As of November 30, 2023, the Company hadone active stock-based equity plan, theCytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan (the “EIP”). As of November 30, 2023 and May 31, 2023, the EIP covered a total of 56.3 million shares of common stock. The Board also made a determination to waive the “evergreen provision” that would have automatically increased the number of shares of common stock subject to the EIP by an amount equal to 1%
of the total outstanding shares on June 1, 2023. The EIP provides for awards of stock options to purchase shares of common stock, restricted and unrestricted shares of common stock, restricted stock units (“RSUs”), and performance share units (“PSUs”).
The Company recognizes the compensation cost of employee and director services received in exchange for equity awards 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 ultimately are not met.
Stock-based compensation for the three months ended November 30, 2023 and 2022 was $0.6 million and $1.8 million, respectively, and for the six months ended November 30, 2023 and 2022 was $1.1 million and $3.1 million, respectively. Stock-based compensation is recorded in general and administrative costs.
Stock options
Stock option activity is presented in the table below:
| · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · · · · · · Weighted · · · | |||||||
| · · · · · · · average · · · | |||||||
| · · · · Weighted · · remaining · · Aggregate | |||||||
| · · Number of · · average · · contractual · · intrinsic | |||||||
| (in thousands, except per share data and years) · shares · exercise price · life in years · value | |||||||
| Options outstanding at May 31, 2023 | 19,823 | | $0.99 | 7.87 | | $— | |
| Granted | 500 | | $0.26 | | | | |
| Exercised | — | | $ | - | | | |
| Forfeited, expired, and cancelled | (692) | | $1.45 | | | | |
| Options outstanding at November 30, 2023 | 19,631 | | $0.96 | 7.46 | | $— | |
| Options outstanding and exercisable at November 30, 2023 | 14,187 | | $1.12 | 6.93 | | $— | |
During the six months ended November 30, 2023 and 2022, stock options for approximately 0.5 million shares and 12.4 million shares, respectively, were granted. The current year options vest when performance conditions are completed. Of the prior year options,10.9 million options vest over four years,1.1 million vested overone year, and 0.4 million vested immediately. 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 $0.23 and $0.34 for the six months ended November 30, 2023 and 2022, respectively.
RSUs and PSUs
The EIP 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 | | remaining contractual |
| (shares in thousands) · RSUs and PSUs (1) · grant date fair value · · life in years | ||||||
| Unvested RSUs and PSUs at May 31, 2023 | 1,293 | | $0.58 | | 0.81 | |
| RSUs and PSUs granted | — | | | — | | |
| RSUs and PSUs forfeited | (1,293) | | | 0.58 | | |
| RSUs and PSUs vested | — | | | — | | |
| Unvested RSUs and PSUs at November 30, 2023 | — | | $— | | — | |
| (1) | The number of PSUs disclosed in this table are at the target level of 100%. |
Issuance of shares to consultants and employees
The Board has approved the issuance under the EIP of shares of common stock to consultants as payment for services provided. During the six months ended November 30, 2023 and 2022, a total of 1,091,865 and 510,872 shares of common stock, respectively, were issued pursuant to the respective award agreements with the consultants.
In order to preserve cash resources, the Board has approved the issuance under the EIP of shares of common stock as severance payments to former employees. During the six months ended November 30, 2023 and 2022 a total of 153,027 and 460,095 shares of common stock, respectively, were issued as severance.
Private placement of common stock and warrants through placement agent
In July 2023, the Company commenced a private placement of units consisting of common stock and warrants to accredited investors through a placement agent. Each unit sold included a fixed combination ofone share of common stock andone warrant to purchaseone share of common stock. The purchase price per unit was $0.16, equal to 90% of the intraday VWAP of the common stock as of the last closing on September 27, 2023. From July through September 2023, the Company sold a total of approximately 21.5 million units for a total of approximately $3.0 million of proceeds, net of issuance costs. The Company classified the securities issued in the private placement as a liability until the final close, when it was reclassified as equity. As part of the offering, the Company issued approximately 21.5 million warrants to investors, with each such warrant having afive-year term and an exercise price of $0.50 per share. The warrants were immediately exercisable. In connection with the above, the Company paid the placement agent a total cash fee of approximately $0.4 million, equal to 12% of the gross proceeds of the offering, as well as a one-time fee for expenses of $5,000, and issued to the placement agent and its designees, a total of approximately 3.2 million warrants with an exercise price of $0.16 per share and aten-year term, representing 15% of the total number of shares of common stock sold in the offering.
Based on contractual payment terms, the private placement transactions above are considered convertible debt instruments prior to final settlement, and the option to enter a final closing that would lower the purchase price is considered a share-settled redemption feature. Therefore, the approximately $0.9 million of cash and non-cash issuance costs associated with such issuances were capitalized and subsequently recognized through the statement of operations as interest expense on the final closing date. As the VWAP of the final closing was lower than the VWAP on the initial closing, the share-settled redemption feature was triggered, and the Company recorded a $2.4 non-cash million loss on note extinguishment.
In addition, approximately $2.3 million principal and interest of the Placement Agent Notes were converted into approximately 14.3 million units with the same terms as described above except for a warrant exercise price of $0.306. See Note 4,Convertible Instruments and Accrued Interest – Placement Agent Notes, andLiability-classified equity instruments above for additional information.
Warrants
Warrant activity is presented in the table below:
| · · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · · · · · · Weighted · · · | ||||||
| · · · · · · · average · · · | ||||||
| · · · · Weighted · · remaining · · Aggregate | ||||||
| · · Number of · · average · · contractual · · intrinsic | ||||||
| (in thousands, except for share data and years) · shares · exercise price · life in years · value | ||||||
| Warrants outstanding at May 31, 2023 | 259,910 | | $0.37 | 4.57 | | $7,276 |
| Granted | 42,019 | | $0.40 | | | |
| Exercised | (3,000) | | $0.10 | | | |
| Forfeited, expired, and cancelled | (5,603) | | $0.75 | | | |
| Warrants outstanding at November 30, 2023 | 293,326 | | $0.37 | 4.31 | | $2,902 |
| Warrants outstanding and exercisable at November 30, 2023 | 293,326 | | $0.37 | 4.31 | | $2,902 |
Warrant exercises
During the six months ended November 30, 2023, the Company issued approximately 3.0 million shares of common stock in connection with the exercise of an equal number of warrants. The stated exercise price was $0.10 per share, which resulted in aggregate gross proceeds of approximately $0.3 million.
Note 6. 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) · · 2023 · 2022 · · 2023 · · 2022 · · | ||||||||||||||
| Net loss | | $(9,563) | | $(26,495) | | $(21,134) | | $(47,486) | | | ||||
| Less: Deemed dividends | | | — | | | (1,140) | | | — | | | (5,294) | | |
| Less: Accrued preferred stock dividends | | | (368) | | | (370) | | | (741) | | | (756) | | |
| Net loss applicable to common stockholders | | $(9,931) | | $(28,005) | | $(21,875) | | $(53,536) | | | ||||
| Basic and diluted: | | | | | | | | | | | | | | |
| Weighted average common shares outstanding | | | 958,988 | | | 813,373 | | | 941,191 | | | 800,545 | | |
| Loss per share | | $(0.01) | | $(0.03) | | $(0.02) | | $(0.07) | | | ||||
The table below shows the approximate number of shares of common stock issuable upon the exercise, vesting, or conversion of outstanding options, warrants, unvested RSUs and PSUs, 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) · 2023 · 2022 · | ||||
| Stock options, warrants, and unvested restricted stock units | 312,956 | | 204,273 | |
| Convertible notes | 12,000 | | 12,000 | |
| Convertible preferred stock | 35,558 | | 32,591 | |
Note 7. 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, 2023 and 2022 waszero. The Company does not consider it more likely than not that the benefits from the net deferred tax assets will be realized; therefore, the Company maintains a full valuation allowance as of November 30, 2023 and May 31, 2023, thus creating a difference between the effective tax rate of 0% and the statutory rate of 21%.
Note 8. Commitments and Contingencies
Commitments with Samsung BioLogics Co., Ltd. (“Samsung”)
In April 2019, the Company entered into several agreements with Samsung, pursuant to which Samsung agreed to perform technology transfer, process validation, manufacturing, pre-approval inspection, and supply services for the commercial supply of leronlimab bulk drug substance. In 2020, the Company entered into an additional agreement, pursuant to which Samsung agreed to perform technology transfer, process validation, vial filling, and storage services for clinical, pre-approval inspection, and commercial supply of leronlimab drug product. Under the agreements, 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 (the “Samsung 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.
On November 21, 2023, Samsung informed the Company of Samsung’s intent to terminate the Samsung Agreements, effective January 5, 2024. As of the date of this filing, the parties remain in communication about the outstanding issues under the agreements and potential options moving forward with Samsung. Under the Samsung Agreements, Samsung may be entitled to terminate its services if the parties cannot agree on the past-due balance. The Company currently holds sufficient leronlimab to conduct its prospective clinical trial(s) in the short term. Management continues to be in contact with Samsung regarding potential approaches to resolve these issues. Samsung paused manufacturing for all unfulfilled commitments not needed by the Company starting in January 2022. Accordingly, the Company has not recorded any accruals associated with the unfulfilled commitments as of November 30, 2023. In the event negotiations are unsuccessful, the Company may have to accrue a liability related to the unfulfilled commitments.
As of November 30, 2023, the Company had past due balances of approximately $32.0 million due to Samsung, which were included in accounts payable.
As of November 30, 2023, the future commitments pursuant to these agreements were estimated as follows (in thousands):
| | | | |
|---|---|---|---|
| Fiscal Year · Amount | |||
| 2024 (6 months remaining) | | $156,388 | |
| 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, Leases, 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, Leases. Operating lease costs for the three months ended November 30, 2023 and 2022 were$32.0 thousand and$46.4 thousand, respectively, and for the six months ended November 30, 2023 and 2022 were 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, 2023 | | | May 31, 2023 | |
| Assets | | | | | | | |
| Right-of-use asset | | $332 | | $400 | | ||
| Liabilities | | | | | | | |
| Current operating lease liability | | $142 | | $139 | | ||
| Non-current operating lease liability | | 211 | | 283 | | ||
| Total operating lease liability | | $353 | | $422 | | ||
The minimum (base rental) lease payments are expected to be as follows as of November 30, 2023 (in thousands):
| | | | |
|---|---|---|---|
| Fiscal Year · · Amount | |||
| 2024 (6 months remaining) | | $91 | |
| 2025 | | | 185 |
| 2026 | | | 169 |
| Thereafter | | | — |
| Total operating lease payments | | | 445 |
| Less: imputed interest | | | (92) |
| Present value of operating lease liabilities | | $353 | |
Supplemental information related to operating leases was as follows:
| | | | |
|---|---|---|---|
| · · November 30, 2023 | |||
| Weighted average remaining lease term | | 2.4 | years |
| Weighted average discount rate | | 10.0% | |
Distribution and licensing commitments
Refer to Note 10,Commitments and Contingencies, in the 2023 Form 10-K for additional information.
Legal proceedings
As of November 30, 2023, the Company did not record any accruals related to the outcomes of the legal 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**s
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 Biologic License Application (“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. All defendants have filed motions to dismiss the second amended complaint in whole or in part. 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 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, a subsidiary of NSF International, Inc., and which had formerly served as the Company’s contract research organization (“CRO”). Mr. Pourhassan was charged withone count of conspiracy, four counts of securities fraud, three counts of wire fraud, andthree counts of insider trading. Mr. Kazempour was charged withone count of conspiracy, three counts of securities fraud, two counts of wire fraud, andone 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, 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, 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. In response, Amarex filed a counterclaim alleging that CytoDyn has failed to pay certain invoices due under the contract between the parties.
On July 10, 2023, the Company filed a Statement of Particulars and requested a final hearing date be set in the proceeding against Amarex. The Statement of Particulars 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 Statement of Particulars 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, among other damages. As the formal arbitration process is still at 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.
Following a formal scheduling request by the Company, the final arbitration hearing was recently ordered to commence on August 19, 2024, and the parties are now in the discovery phase of the litigation.
Note 9. Subsequent Events
Issuance of Short-term Notes
In December 2023, the Company entered into securities purchase agreements pursuant to which the Company issued Short-term Notes with asix-month term to accredited investors in the aggregate principal amount of approximately $0.8 million through a placement agent. The Company also issued warrants to purchase approximately 0.8 million shares of common stock with afive-year term and an exercise price of $0.35 as part of the debt issuance. The Company also issued warrants to purchase approximately 0.4 million shares of common stock to the placement agent with aten-year term. The exercise price for the warrants issued to the placement agent was determined to be $0.35 per share, based on the intraday VWAP of the Company’s stock on December 7, 2023. The net proceeds of approximately $0.7 million reflect issuance costs of approximately $0.1 million.
The principal and accrued interest on the Short-term Notes were converted into units based on a price of$0.14 per unit, which represented 80% of the unit pricing in the offering described above. Units for a total of approximately 7.2 million shares of common stock and additional fully exercisable warrants to purchase a total of approximately 7.2 million shares of common stock at a price of $0.35 per share were issued to the investors in connection with the conversion.
Private placement of common stock and warrants through placement agent
In December 2023, the Company commenced a private placement of units consisting of common stock and warrants to accredited investors through a placement agent. Each unit sold included a fixed combination ofone share of common stock andone warrant to purchaseone share of common stock. Each unit has a purchase price of $0.17, which was equal to 90% of the closing price of the common stock on December 29, 2023. During December 2023, the Company sold a total of approximately 10.3 million units for a total of approximately $1.5 million of proceeds, net of issuance costs. The Company classified the securities issued in the private placement through the placement agent as a liability until the final issuance date. As part of the offering, the Company will issue approximately 10.3 million warrants to investors, with each such warrant having afive-year term and an exercise price of $0.35 per share. The warrants were immediately exercisable. In connection with the above, the Company paid the placement agent a total cash fee of approximately $0.2 million, equal to 13% of the gross proceeds of the offering, as well as a one-time fee for expenses of $5.0 thousand, and will issue a total of approximately 1.5 million warrants with an exercise price of $0.17 per share and aten-year term, representing 15% of the total number of common stock sold in the offering, to the placement agent and its designees.
Induced note conversions
During December 2023, in satisfaction of redemptions, the Company and the April 2, 2021 Noteholder entered into exchange agreements, pursuant to which a portion of the April 2, 2021 Note was partitioned into new notes with an aggregate principal amount of approximately $1.3 million, which were exchanged concurrently with the issuance of approximately 8.3 million shares of common stock.
Stock option cancellations and issuances
On January 3, 2024, the Board’s Compensation Committee approved the grant of nonqualified stock options to purchase a total of 10,750,779 shares of common stock under the EIP with an exercise price of $0.21 per share. The grants covered a total of (i)4,000,000 options granted to the Company’sfive directors; (ii)2,980,222 options granted totwo of the Company’s executive officers; and (iii)3,770,557 options granted to non-executive employees of the Company. The Compensation Committee also approved the cancellation of a total of 4,060,779 outstanding options with exercise prices ranging from $0.41 to $5.57 per share held by executive officers and non-executive employees, with an equal number of options with the same vesting schedules and expiration dates as the cancelled options issued as replacement options as part of the January 3, 2024 option grants. The remaining 6,690,000 options have aten-year term, with the options granted to directors vesting through May 31, 2024, and those granted to officers and employees vesting through May 31, 2027.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.