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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended November 30, 2024

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1933

For the transition period from                  to                 

Commission File Number: 000-49908

CYTODYN INC.

(Exact name of registrant as specified in its charter)

Delaware

83-1887078

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer or

Identification No.)

 

 

1111 Main Street, Suite 660

Vancouver, Washington

98660

(Address of principal executive offices)

(Zip Code)

(360) 980-8524

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class 

    

Trading
Symbol(s)

    

Name of Each Exchange
on Which Registered

None

None

None

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer

Accelerated Filer

 

 

 

 

Non-accelerated Filer

Smaller Reporting Company

 

 

 

 

 

 

Emerging Growth Company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):    Yes      No  

On December 31, 2024, there were 1,228,232 thousand shares outstanding of the registrant’s $0.001 par value common stock.

PART I. Financial Information

Item 1. Consolidated Financial Statements

CytoDyn Inc.

Consolidated Balance Sheets

(Unaudited, in thousands, except par value)

November 30, 2024

    

May 31, 2024

Assets

 

Current assets:

 

 

  

Cash and cash equivalents

$

21,335

$

3,110

Restricted cash

 

 

6,704

Prepaid expenses

 

635

 

463

Prepaid service fees

 

663

 

538

Other receivables (Note 9)

2,000

Total current assets

 

24,633

 

10,815

Other non-current assets

 

244

 

321

Total assets

$

24,877

$

11,136

Liabilities and Stockholders’ Deficit

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

14,244

$

29,561

Accrued liabilities and compensation

 

2,767

 

2,810

Accrued interest on convertible notes

 

17,553

 

15,227

Accrued dividends on convertible preferred stock

 

7,532

 

6,791

Convertible notes payable, net

 

28,531

 

29,793

Total current liabilities

 

70,627

 

84,182

Operating leases

 

69

 

141

Other liabilities (Note 9)

43,571

43,571

Total liabilities

 

114,267

 

127,894

Commitments and Contingencies (Note 9)

 

  

 

  

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, 2024 and May 31, 2024

 

 

Series C convertible preferred stock, $0.001 par value; 8 authorized; 6 issued and outstanding at November 30, 2024 and May 31, 2024

 

 

Series D convertible preferred stock, $0.001 par value; 12 authorized; 9 issued and outstanding at November 30, 2024 and May 31, 2024

 

 

Common stock, $0.001 par value; 1,750,000 shares authorized; 1,223,517 and 1,059,002 issued, and 1,223,075 and 1,058,559 outstanding at November 30, 2024 and May 31, 2024, respectively

 

1,224

 

1,059

Treasury stock, $0.001 par value; 443 shares at November 30, 2024 and May 31, 2024

Additional paid-in capital

 

786,458

 

773,714

Accumulated deficit

 

(877,072)

 

(891,531)

Total stockholders’ deficit

 

(89,390)

 

(116,758)

Total liabilities and stockholders' deficit

$

24,877

$

11,136

See accompanying notes to consolidated financial statements.

3

CytoDyn Inc.

Consolidated Statements of Operations

(Unaudited, in thousands, except per share data)

Three months ended November 30,

Six months ended November 30,

    

2024

    

2023

    

2024

    

2023

Operating expenses:

 

  

 

  

 

  

 

  

General and administrative

$

2,294

$

2,311

$

3,898

$

4,999

Research and development

 

1,409

 

1,079

 

(22,637)

 

2,993

Depreciation

 

4

 

8

 

9

 

18

Total operating expenses

 

3,707

 

3,398

 

(18,730)

 

8,010

Operating (loss) gain

 

(3,707)

 

(3,398)

 

18,730

 

(8,010)

Interest and other income (expense):

Interest income

142

268

Interest expense on convertible notes

 

(1,161)

 

(1,164)

 

(2,326)

 

(2,361)

Amortization of discount on convertible notes

(113)

(142)

(238)

(542)

Amortization of debt issuance costs

 

 

(3)

 

 

(369)

Issuance costs for private placement of shares and warrants through placement agent

(906)

(906)

Loss on induced conversion

 

(636)

(1,180)

(2,640)

Finance charges

 

(9)

 

(891)

 

(23)

 

(1,803)

Loss on note extinguishment

 

 

(2,406)

 

 

(4,490)

Gain on restructuring of payables

 

80

 

 

80

 

Loss on derivatives

(17)

(852)

(13)

Total interest and other expenses

 

(1,061)

 

(6,165)

 

(4,271)

 

(13,124)

(Loss) gain before income taxes

 

(4,768)

 

(9,563)

 

14,459

 

(21,134)

Income tax benefit

 

 

 

 

Net (loss) income

$

(4,768)

$

(9,563)

$

14,459

$

(21,134)

(Loss) income per share:

Basic

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

Diluted

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

Weighted average common shares used in calculation of (loss) income per share:

Basic

1,221,405

958,988

1,177,988

941,191

Diluted

1,221,405

958,988

1,204,193

941,191

See accompanying notes to consolidated financial statements.

4

CytoDyn Inc.

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, 2024

34

$

1,059,002

$

1,059

443

$

$

773,714

$

(891,531)

$

(116,758)

Issuance of stock for convertible note repayment

8,777

9

 

991

 

 

1,000

Loss on induced conversion

 

1,180

 

 

1,180

Stock issued for tender offer

152,505

152

 

13,874

 

 

14,026

Issuance costs related to stock issued for tender offer

 

(3,649)

 

 

(3,649)

Dividends accrued on Series C and D convertible preferred stock

 

(372)

 

 

(372)

Stock-based compensation

 

136

 

 

136

Net income

 

 

19,227

 

19,227

Balance at August 31, 2024

34

1,220,284

1,220

443

785,874

(872,304)

(85,210)

Issuance of stock for convertible note repayment

3,233

4

416

 

420

Dividends accrued on Series C and D convertible preferred stock

(369)

 

(369)

Stock-based compensation

537

 

537

Net loss

(4,768)

 

(4,768)

Balance at November 30, 2024

34

$

1,223,517

$

1,224

443

$

$

786,458

$

(877,072)

$

(89,390)

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)

See accompanying notes to consolidated financial statements.

5

CytoDyn Inc.

Consolidated Statements of Cash Flows

(Unaudited, in thousands)

Six months ended November 30,

    

2024

    

2023

Cash flows from operating activities:

 

  

 

Net income (loss)

$

14,459

$

(21,134)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

 

  

 

  

Depreciation

 

9

 

18

Amortization of debt issuance costs

 

 

369

Issuance costs for private placement of shares and warrants through placement agent

906

Amortization of discount on convertible notes

 

238

 

542

Gain on restructuring of payables

(80)

Loss on derivatives

852

13

Loss on induced conversion

1,180

2,640

Loss on note extinguishment

 

 

4,490

Stock-based compensation

 

673

 

1,075

Changes in operating assets and liabilities:

 

 

  

Prepaid expenses and other assets

(2,229)

(290)

Accounts payable, accrued expenses, and other liabilities

 

(13,248)

 

4,374

Net cash provided by (used in) operating activities

 

1,854

 

(6,997)

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

10,377

Proceeds from sale of common stock and warrants, net of issuance costs

 

 

3,016

Proceeds from warrant exercises

 

 

300

Proceeds from convertible note and warrant issuances, net of offering costs

 

 

1,357

Cash paid for note payable

(710)

Net cash provided by financing activities

 

9,667

 

4,673

Net change in cash and restricted cash

 

11,521

 

(2,324)

Cash, cash equivalents, and restricted cash at beginning of period

 

9,814

 

9,048

Cash, cash equivalents, and restricted cash at end of period

$

21,335

$

6,724

Cash, cash equivalents, and restricted cash consisted of the following:

Cash and cash equivalents

$

21,335

$

147

Restricted cash

6,577

Total cash, cash equivalents, and restricted cash

$

21,335

$

6,724

Supplemental disclosure:

Cash paid for interest

$

23

$

38

Non-cash investing and financing transactions:

 

  

 

  

Derivative liability associated with warrants

$

$

80

Issuance of common stock for principal of convertible notes

$

1,420

$

2,000

Accrued dividends on Series C and D convertible preferred stock

$

741

$

741

Warrants issued to placement agent

$

$

413

Note conversion to common stock and warrants

$

$

2,295

See accompanying notes to consolidated financial statements.

6

CYTODYN INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

AS OF NOVEMBER 30, 2024

(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 is currently working to further establish leronlimab via clinical development of its effects on oncology, inflammation and a number of other potential exploratory indications. Historically, the Company has investigated leronlimab as a viral entry inhibitor 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, solid tumors in oncology, COVID-19, Long-COVID, and human immunodeficiency virus (“HIV”) indications where CCR5 is believed to play an integral role in the pathogenesis of disease.

Note 2. Summary of Significant Accounting Policies

Basis of presentation

The unaudited 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, 2024, as amended by Amendment No. 1 on Form 10-K/A (the “2024 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.

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, except for the six months ended November 30, 2024. The Company has an accumulated deficit of approximately $877.1 million as of November 30, 2024. These factors, among others, including the various matters discussed in Note 9, 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 generate 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

7

development expenses in the future, primarily related to its regulatory compliance, including 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 unaudited consolidated financial statements have been prepared in accordance with GAAP, which 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 discussions with the U.S. Food and Drug Administration (“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 other assumptions that are believed to be reasonable under the circumstances. Significant estimates include, but are not limited to, those relating to stock-based compensation, the assumptions used to value warrants, and warrant modifications. Actual results could differ from these estimates.

Cash and cash equivalents

Cash and cash equivalents are short-term, highly liquid investments with original maturities of three months or less when purchased and comprise bank deposits and money market funds. Our investments in money market funds are measured at fair value on a recurring basis and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The value of the money market fund as of November 30, 2024 was approximately $19.1 million with a zero investment as of May 31, 2024.

Restricted cash

As of November 30, 2024, the Company had no restricted cash. The restricted cash in the prior period was related to cash that was being held as collateral as required in the Amarex Clinical Research L.L.C. (“Amarex”) litigation and was released in full on July 2, 2024, as part of the settlement agreement.

Fair value of financial instruments

In accordance with the prescribed accounting guidance, the Company measured fair value of derivative 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.

8

Recent Accounting Pronouncements

In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 Accounting Standards Codification (“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.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The standard is intended to improve annual and interim reportable segment disclosure requirements regardless of the number of reporting units, primarily through enhanced disclosure of significant expenses. The amendment requires public entities to disclose significant segment expenses that are regularly provided to the CODM and included with each reported measure of segment profit and loss. The standard is effective for annual periods beginning after December 15, 2023. Early adoption is permitted and the amendments in this update should be applied retrospectively to all periods presented. The Company is currently evaluating the impact of this update on its financial statement disclosures but does not believe it will materially impact the financial statements.

In December 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.

In November 2024, the FASB issued ASU 2024-03, “Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses," which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. The amendments in this ASU will be effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently assessing the potential impacts of adoption on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-04, "Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments," which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion or extinguishment of convertible debt. The new guidance is effective for annual reporting periods beginning after December 15, 2025, and interim periods within those annual periods. The Company is currently evaluating the impact of the standard on its consolidated financial statements and related disclosures.

9

Note 3. Accrued Liabilities and Compensation

The components of accrued liabilities and compensation are as follows (in thousands):

November 30, 2024

May 31, 2024

Compensation and related expense

$

214

$

208

Legal fees and settlement

111

7

Clinical expense

284

329

License fees

1,875

1,799

Lease payable

141

142

Investor proceeds held in escrow

300

Other liabilities

142

25

Total accrued liabilities

$

2,767

$

2,810

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, 2024

May 31, 2024

(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

$

22

$

$

$

19

$

$

Accrued dividends

$

$

3,453

$

4,079

$

$

3,135

$

3,656

Total shares of common stock if dividends converted

44

6,906

8,158

38

6,270

7,312

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 election 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.

10

Convertible Notes and Accrued Interest

The table below presents outstanding convertible notes and accrued interest as of November 30, 2024 and May 31, 2024:

November 30, 2024

May 31, 2024

(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

$

2,831

$

25,869

$

28,700

$

2,831

$

27,369

$

30,200

Less: Unamortized debt discount and issuance costs

(17)

(152)

(169)

(45)

(362)

(407)

Convertible notes payable, net

2,814

25,717

28,531

2,786

27,007

29,793

Accrued interest on convertible notes

5,024

12,529

17,553

4,634

10,593

15,227

Outstanding convertible notes payable, net and accrued interest

$

7,838

$

38,246

$

46,084

$

7,420

$

37,600

$

45,020

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, 2024

$

7,420

$

37,600

$

45,020

Consideration received

Amortization of issuance discount and costs

28

210

238

Interest expense

390

1,936

2,326

Fair market value of shares and warrants exchanged for repayment

(1,600)

(1,600)

Difference between market value of
common shares and reduction of principal

100

100

Outstanding balance at November 30, 2024

$

7,838

$

38,246

$

46,084

April 2, 2021 & April 23, 2021 Notes

Key terms of the outstanding convertible notes (the “Notes”) are as follows:

November 30, 2024

    

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 Notes 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 Notes 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, 2024, in satisfaction of redemptions, the Company and April 23, 2021 Noteholder entered into exchange agreements, pursuant to which the April 23, 2021 Note was partitioned into new notes (the “Partitioned Notes”) with an aggregate principal amount of $1.5 million, which was exchanged concurrently with the issuance of approximately 12.0 million shares of common stock. The outstanding balance of the April 23, 2021 Note was reduced by the Partitioned Notes to a principal amount of $25.9 million. The Company accounted for the Partitioned

11

Notes and the exchange settlements where the shares exchanged were worth less than principal extinguished as induced conversions, and, accordingly, recorded a non-cash loss on convertible debt induced conversion of approximately $1.2 million for the six months ended November 30, 2024. The Company recognized an approximate $0.1 million gain on restructuring of payables during the six months ended November 30, 2024 for the Partitioned Notes and the exchange settlement where the shares exchanged were worth more than principal extinguished.

As of December 31, 2024, the holders of the Notes waived all provisions 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, 2024.

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 (the “Placement Agent Notes”) for a total principal amount of approximately $2.3 million. 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.

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 of one share plus one 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. The amendment also allowed investors to retain an interest in the Amarex settlement after conversion.

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 6, Private Placements of Common Stock and Warrants – Private placements of common stock and warrants through placement agent in the Company’s 2024 Form 10-K.

Due to the settlement with Amarex in July 2024, the Company owed approximately $0.9 million to Placement Agent Note investors, recorded as a loss on derivatives, of which approximately $0.7 million was paid in the six months ended November 30, 2024. In accordance with the prescribed accounting guidance, the Company measured the fair value of liability classified warrants using fair value hierarchy included in Note 2, Summary of Significant Accounting Policies – Fair Value of Financial Instruments. The Company’s derivative liability is classified within Level 3.

Please refer to Note 5, Convertible Instruments and Accrued Interest, in the Company’s 2024 Form 10-K for additional information.

12

Note 5. Private Placements of Common Stock and Warrants

Tender offer

On July 19, 2024, the Company closed a tender offer in which warrants to purchase approximately 127.1 million shares of common stock were exercised at a $0.09387 exercise price, resulting in gross proceeds of approximately $11.9 million and net proceeds of approximately $10.4 million. The Company also issued approximately 25.4 million shares of common stock as bonus shares in the tender offer. The Company paid the placement agent a total cash fee of approximately $1.4 million, equal to 13% of the gross proceeds of the offering, as well as repricing all warrants previously issued to the placement agent to $0.09387 per share. In connection with the tender offer, the Company recognized the following issuance costs: $1.4 million in cash paid to the placement agent, $0.1 million in legal fees, a $1.7 million change in fair value of the exercised warrants, and a $0.4 million change in fair value due to repricing the placement agent warrants.

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, 2024

 

361,445

$

0.34

 

4.21

$

2,697

Granted

 

$

 

 

Exercised

 

(127,087)

$

0.09

 

 

Forfeited, expired, and cancelled

 

(4,729)

$

0.37

 

 

Warrants outstanding at November 30, 2024

 

229,629

$

0.26

 

4.08

$

1,269

Warrants outstanding and exercisable at November 30, 2024

 

229,629

$

0.26

 

4.08

$

1,269

Note 6. Equity Incentive Plan

Equity Incentive Plan

As of November 30, 2024, the Company had one active equity incentive plan, the CytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan (the “EIP”). As of November 30, 2024 and May 31, 2024, the EIP covered a total of 66.8 million and 56.3 million shares of common stock, respectively. The “evergreen provision” 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, 2024. 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. Share-based compensation cost is recognized over the period during which the employee or director is required to provide services 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.

 

13

Stock-based compensation for the three months ended November 30, 2024 and 2023 was $0.5 million and $0.6 million, respectively, and for the six months ended November 30, 2024 and 2023 was $0.7 million and $1.1 million, respectively. Stock-based compensation is recorded in general and administrative and research and development 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, 2024

 

25,849

$

0.60

 

7.77

$

Granted

 

11,675

$

0.14

 

 

Exercised

 

$

 

 

Forfeited, expired, and cancelled

 

(50)

$

0.66

 

 

Options outstanding at November 30, 2024

 

37,474

$

0.46

 

8.10

$

Options outstanding and exercisable at November 30, 2024

 

23,858

$

0.61

 

7.30

$

During the six months ended November 30, 2024 and 2023, stock options for approximately 11.7 million shares and 0.5 million shares, respectively, were granted. Of the current year options, approximately 5.7 million vest over four years, and approximately 6.0 million vest over one year. The prior year options vest when performance conditions are met. 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 $0.12 and $0.23 for the stock options granted in the six months ended November 30, 2024 and 2023, respectively.

Note 7. (Loss) Income per Share

Basic (loss) income per share is computed by dividing the net (loss) income adjusted for preferred stock dividends by the weighted average number of common shares outstanding during the period. Diluted (loss) income per share includes the weighted average common shares outstanding and potentially dilutive common stock equivalents. Basic and diluted (loss) income per share for the three and six months ended November 30, 2024 were calculated as follows:

Three months ended November 30,

Six months ended November 30,

(in thousands, except per share amounts)

2024

    

2023

2024

2023

Numerator:

Net (loss) income

$

(4,768)

$

(9,563)

$

14,459

$

(21,134)

Less: Accrued preferred stock dividends

(369)

(368)

(741)

(741)

Net (loss) income applicable to common stockholders

$

(5,137)

$

(9,931)

$

13,718

$

(21,875)

Denominator:

Basic weighted average common shares outstanding

1,221,405

958,988

1,177,988

941,191

Effect of dilutive securities:

Warrant exercises

26,205

Diluted weighted average common shares outstanding

1,221,405

958,988

1,204,193

941,191

Basic (loss) income per share

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

Diluted (loss) income per share

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

The table below shows the approximate number of shares of common stock issuable upon the exercise, vesting, or conversion of outstanding options, warrants, convertible notes, and convertible preferred stock (including undeclared

14

dividends) that were not included in the computation of diluted weighted average number of shares of common stock outstanding for the periods presented:

Three and six months ended November 30,

(in thousands)

2024

    

2023

Stock options, warrants, and unvested restricted stock units

240,898

312,956

Convertible notes

12,000

12,000

Convertible preferred stock

38,533

35,558

Note 8. Income Taxes

To determine the Company’s quarterly provision for income taxes, the Company used an estimated annual effective tax rate that is based on expected annual income and statutory tax rates in the various jurisdictions in which the Company operates. Certain significant unusual or infrequently occurring items that are separately reported are separately recognized in the quarter during which they occur and can be a source of variability in the effective tax rate from quarter to quarter.

The Company had no income tax expense for the three and six months ended November 30, 2024 and 2023. The provision for income taxes for the three and six months ended November 30, 2024 and 2023 is based on the Company’s estimated annualized effective tax rate for the fiscal years ending May 31, 2025 and 2024, respectively. For the three and six months ended November 30, 2024, the Company’s recognized effective tax rate differs from the U.S. federal statutory rate due to the Company maintaining a full valuation allowance on its net deferred tax assets, as the Company does not consider it more likely than not that the benefits from the net deferred tax assets will be realized.

Note 9. Commitments and Contingencies

Commitments with Samsung BioLogics Co., Ltd. (“Samsung”)

On April 3, 2024, the Company and Samsung executed a side letter agreement (the “Side Letter”), wherein the parties reached an agreement for an orderly process for winding down services and a restructuring of the amount payable by the Company to Samsung (the “Total Balance”). The Total Balance due to Samsung, as restructured under the Side Letter, is approximately $43.8 million. Except for a single $250,000 payment that was due and paid before December 31, 2024, the entirety of the Total Balance is conditional, and will only be due and payable, upon the Company achieving a qualifying “Revenue” event, as defined in the Side Letter. Under the Side Letter, the Company has agreed to pay 20% of its qualifying Revenue generated in each calendar year, if any, with such payments to be applied to reduce the Total Balance until it is repaid in full. Interest will not accrue on the Total Balance throughout the prospective repayment period. Revenue is defined in the Side Letter as:

“…the gross revenue generated by Client and its Affiliates, less the following items (if not previously deducted from the amount invoiced): (a) reasonable and customary trade, quantity, and cash discounts actually granted and legally permitted wholesaler chargebacks actually paid or credited by Client and its Affiliates to wholesalers of products; (b) reasonable, customary, and legally permitted rebates and retroactive price reductions actually granted; (c) freight charges for the delivery of products; (d) the portion of the administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers and/or government-mandated Medicare or Medicaid Prescription Drug Plans relating specifically to the product; and (e)

15

sales, use or excise taxes imposed and actually paid in connection with the sale of products (but excluding any value added taxes or taxes based on income or gross receipts).”

The $250,000 payment that was due and paid before December 31, 2024, is included in accounts payable, and the remaining balance of approximately $43.6 million is included in other long-term liabilities.

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, 2024 and 2023 were approximately $32.0 thousand and $32.0 thousand, respectively and for the six months ended November 30, 2024 and 2023 were approximately $0.1 million and $0.1 million. 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, 2024

May 31, 2024

Assets

Right-of-use asset

$

196

$

264

Liabilities

Current operating lease liability

$

141

$

142

Non-current operating lease liability

 

69

 

141

Total operating lease liability

$

210

$

283

The minimum (base rental) lease payments are expected to be as follows as of November 30, 2024 (in thousands):

Fiscal Year

Amount

2025 - 6 months remaining

$

92

2026

169

Thereafter

Total operating lease payments

261

Less: imputed interest

(51)

Present value of operating lease liabilities

$

210

Supplemental information related to operating leases was as follows:

November 30, 2024

Weighted average remaining lease term

1.4

years

Weighted average discount rate

10.0

%

Commitments with Contract Research Organization

The Company has entered into a project work order for the colorectal cancer clinical trial with our CRO, Syneos Health. In the event of an early termination of the trial, the Company may incur a cancellation fee of up to 5% of the remaining project budget, in addition to any direct, indirect and pass-through costs incurred to wind down the trial.

16

Distribution and licensing commitments

Refer to Note 10, Commitments and Contingencies, in the 2024 Form 10-K for additional information.

Legal proceedings

As of November 30, 2024, the Company did not record any accruals related to the outcomes of the legal matters described below. It is not 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 Lawsuits

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, as amended (the “Exchange Act”) 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, 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.

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

17

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.

On January 29, 2024, two purported stockholders filed a purported derivative lawsuit against certain of the Company’s former officers, certain current and former directors, and the Company as a nominal defendant, in the Delaware Court of Chancery. The complaint generally makes allegations similar to those set forth in the Consolidated Derivative Suit and asserts that the individual defendants breached their fiduciary duties by allowing the Company to make false and misleading statements and by failing to maintain an adequate system of oversight and controls. The complaint also asserts claims against certain individual defendants for breach of fiduciary duty arising from alleged insider trading.

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 suit(s) is/are in an early stage and the claims do not specify an amount of damages, the Company cannot predict the ultimate outcome of the matter(s) 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 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 and will continue to comply with the requests of each agency. In December 2024, a federal jury convicted Mr. Pourhassan and Mr. Kazempour after trial on a number of counts. Mr. Pourhassan and Mr. Kazempour are set to be sentenced in April 2025. The Company cannot predict the ultimate outcome of the DOJ or SEC investigations. 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,

18

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.

Settlement of Amarex Dispute

On July 2, 2024, the Company and Amarex, the Company’s former CRO, entered into an agreement settling a lawsuit filed by the Company in October 2021 (the “Settlement Agreement”).

The terms of the Settlement Agreement include: (i) the payment by Amarex of $12,000,000 to the Company, of which $10,000,000 was paid on execution of the Settlement Agreement and the balance will be paid on or before July 2, 2025; (ii) the release of the Company’s surety bond posted in the lawsuit and the return of the Company’s cash collateral in the amount of $6,500,000 provided as security to the surety; (iii) the crediting of all amounts claimed by Amarex as due and payable for its CRO services, totaling approximately $14,000,000, reducing the Company’s outstanding balance to zero, with no funds required to be paid by the Company; and (iv) a mutual release of claims, resolving all legal claims between the parties. The effect of the Settlement Agreement is recorded in research and development expense.

Note 10. Subsequent Events

Note conversion

During December 2024, in satisfaction of a redemption, the Company and the April 23, 2021 Noteholder entered into an exchange agreement, pursuant to which a portion of the April 23, 2021 Note was partitioned into a new note with an aggregate principal amount of approximately $0.8 million, which was exchanged concurrently with the issuance of approximately 5.2 million shares of common stock.

19

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Certain information included in this quarterly report on Form 10-Q contains, or incorporates by reference, forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking.

Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements. In evaluating all such statements, we urge you to specifically consider various risks identified elsewhere in this quarterly report, and those set forth in Item 1A. Risk Factors in the 2024 Form 10-K, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.

Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information about current business plans.

Forward-looking statements include, among others, statements about leronlimab, its ability to have positive health outcomes, the Company’s ability to implement a successful operating strategy for the development of leronlimab and thereby create shareholder value, the ability to obtain regulatory approval of the Company’s drug products for commercial sales, and the strength of the Company’s leadership team. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties, including: (i) the regulatory determinations of leronlimab’s safety and effectiveness to treat the disease and conditions for which we are studying the product by the FDA and, potentially, drug regulatory agencies in other countries; (ii) the Company’s ability to raise additional capital to fund its operations; (iii) the Company’s ability to meet its debt and other payment obligations; (iv) the Company’s ability to enter into or maintain partnership or licensing arrangements with third parties; (v) the Company’s ability to recruit and retain key employees; (vi) the timely and sufficient development, through internal resources or third-party consultants, of analyses of the data generated from the Company’s clinical trials required by the FDA or other regulatory agencies in connection with applications for approval of the Company’s drug product; (vii) the Company’s ability to achieve approval of a marketable product; (viii) the design, implementation and conduct of clinical trials; (ix) the results of any such clinical trials, including the possibility of unfavorable clinical trial results; (x) the market for, and marketability of, any product that is approved; (xi) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products; (xii) regulatory initiatives, compliance with governmental regulations and the regulatory approval process; (xiii) legal proceedings, investigations or inquiries affecting the Company or its products; (xiv) stockholder actions or proposals with regard to the Company, its management, or its Board of Directors; (xv) general economic and business conditions; (xvi) changes in foreign, political, and social conditions; (xvii) and various other matters, many of which are beyond the Company’s control.

We intend that all forward-looking statements made in this quarterly report will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act and Section 21E of the Exchange Act, to the extent applicable. Except as required by law, we do not undertake any responsibility to update these forward-looking statements to address events or circumstances that occur after the date of this quarterly report. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events that may cause actual results to differ from those expressed or implied by these forward-looking statements.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our 2024 Form 10-K, and the other sections of this Form 10-Q, including our consolidated financial statements and related notes set forth in Part I, Item 1. This discussion and analysis contain forward-looking statements, including information about possible or assumed results of our financial condition, operations, plans, objectives and performance that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated and set forth in such forward-looking statements.

20

Overview and Corporate Developments

The Company is a clinical stage biotechnology company focused on the clinical development and potential commercialization of its product candidate, leronlimab, which is being studied for oncology and inflammation, as well as other potential indications.

Our current business strategy is the clinical development of leronlimab, which includes the following:

1.Conduct studies exploring leronlimab and its therapeutic potential in oncology, including a Phase II trial of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer;
2.Conduct studies exploring leronlimab and its effects on inflammation; and
3.Continue our work researching and developing a new or modified long-acting version of leronlimab.

Other current programs that may be pursued include liver or other organ fibrosis, either alone or as a combination therapy.

We may need significant additional funding to execute the above business strategy in full, which may include conducting a variety of additional pre-clinical studies and clinical trials, in furtherance of our efforts to obtain FDA approval to commercialize leronlimab. In addition to traditional fundraising the Company will pursue non-dilutive financing opportunities, such as license agreements and co-development or strategic partnerships, to help implement its strategy.

Results of Operations

Fluctuations in operating results

The Company’s operating results may fluctuate significantly depending on the outcomes, number and timing of pre-clinical and clinical studies, patient enrollment and/or completion rates in the studies, and their related effect on research and development expenses, regulatory and compliance activities, activities related to seeking FDA approval of our drug product, general and administrative expenses, professional fees, and legal and regulatory proceedings and related consequences. We require a significant amount of capital to continue to operate; therefore, we regularly conduct financing offerings to raise capital, which may result in various forms of non-cash interest expense or other expenses. Additionally, we periodically seek to negotiate settlement of debt payment obligations in exchange for equity securities of the Company and enter into warrant exchanges or modifications that may result in non-cash charges. Our ability to continue to fund operations will depend on our ability to raise additional funds. See the Liquidity and Capital Resources and Going Concern sections in this Item 2 of Part I and Item 1A. Risk Factors in our 2024 Form 10-K.

21

The results of operations were as follows for the periods presented:

Three months ended November 30,

Change

Six months ended November 30,

Change

(in thousands, except for per share data)

    

2024

    

2023

    

$

    

%

    

2024

    

2023

    

$

    

%

Operating expenses:

  

  

General and administrative

$

2,294

 

$

2,311

$

(17)

(1)

%

$

3,898

 

$

4,999

$

(1,101)

(22)

%

Research and development

 

1,409

 

 

1,079

 

330

31

 

(22,637)

 

 

2,993

 

(25,630)

(856)

Depreciation

 

4

 

 

8

 

(4)

(50)

 

9

 

 

18

 

(9)

(50)

Total operating expenses

 

3,707

 

 

3,398

 

309

9

 

(18,730)

 

 

8,010

 

(26,740)

(334)

Operating (loss) gain

 

(3,707)

 

 

(3,398)

 

(309)

(9)

 

18,730

 

 

(8,010)

 

26,740

334

Interest and other income (expense):

Interest income

 

142

142

100

268

268

100

Interest expense on convertible notes

 

(1,161)

(1,164)

3

0

(2,326)

(2,361)

35

1

Amortization of discount on convertible notes

 

(113)

 

 

(142)

 

29

20

 

(238)

 

 

(542)

 

304

56

Amortization of debt issuance costs

(3)

3

100

(369)

369

100

Issuance costs for private placement of shares and warrants through placement agent

(906)

906

100

(906)

906

100

Loss on induced conversion

(636)

636

100

(1,180)

(2,640)

1,460

55

Finance charges

 

(9)

 

 

(891)

 

882

99

 

(23)

 

 

(1,803)

 

1,780

99

Loss on note extinguishment

 

 

 

(2,406)

 

2,406

100

 

 

 

(4,490)

 

4,490

100

Gain on restructuring of payables

 

80

 

 

 

80

100

 

80

 

 

 

80

100

Loss on derivatives

(17)

17

100

(852)

(13)

(839)

(6,454)

Total interest and other expenses

 

(1,061)

 

 

(6,165)

 

5,104

83

 

(4,271)

 

 

(13,124)

 

8,853

67

(Loss) gain before income taxes

 

(4,768)

 

 

(9,563)

 

4,795

50

 

14,459

 

 

(21,134)

 

35,593

168

Income tax benefit

 

 

 

 

Net (loss) income

$

(4,768)

 

$

(9,563)

$

4,795

50

%

$

14,459

$

(21,134)

$

35,593

168

%

(Loss) income per share:

 

Basic

$

(0.00)

$

(0.01)

$

0.01

58

$

0.01

$

(0.02)

$

0.03

150

Diluted

$

(0.00)

$

(0.01)

$

0.01

58

%

$

0.01

 

$

(0.02)

$

0.03

150

%

Weighted average common shares used in calculation of (loss) income per share:

Basic

1,221,405

958,988

262,417

27

1,177,988

941,191

236,797

25

Diluted

1,221,405

958,988

262,417

27

%

1,204,193

941,191

263,002

28

%

22

General and administrative (“G&A”) expenses

G&A expenses consisted of the following:

Three months ended November 30,

Change

Six months ended November 30,

Change

(in thousands)

2024

    

2023

    

$

    

%

    

2024

    

2023

    

$

    

%

Salaries, benefits, and other compensation

$

335

$

461

$

(126)

(27)

%

$

760

$

1,103

$

(343)

(31)

%

Stock-based compensation

 

320

 

572

(252)

(44)

 

456

 

1,075

(619)

(58)

Legal fees

763

476

287

60

1,139

793

346

44

Insurance

320

521

(201)

(39)

643

937

(294)

(31)

Other

 

556

 

281

275

98

 

900

 

1,091

(191)

(18)

Total general and administrative

$

2,294

$

2,311

$

(17)

(1)

%

$

3,898

$

4,999

$

(1,101)

(22)

%

The decrease in G&A expenses for the three- and six-month periods ended November 30, 2024, compared to the same period in the prior year, was primarily due to a reduction in Stock-based compensation and Salaries, benefits and other compensation due to classifying clinical employees’ compensation as a research and development expense in the current fiscal year.

Research and development (“R&D”) expenses

R&D expenses consisted of the following:

Three months ended November 30,

Change

Six months ended November 30,

Change

(in thousands)

2024

    

2023

    

$

    

%

    

2024

    

2023

    

$

    

%

Clinical

$

823

$

277

$

546

197

%

$

1,560

$

1,528

$

32

2

%

Non-clinical

 

343

 

237

106

45

 

329

 

488

(159)

(33)

CMC

 

390

 

319

71

22

 

360

 

488

(128)

(26)

 

License and patent fees

 

(147)

 

246

(393)

(160)

 

99

 

489

(390)

(80)

 

Return of clinical expenses

(24,985)

(24,985)

100

Total research and development

$

1,409

$

1,079

$

330

31

%

$

(22,637)

$

2,993

$

(25,630)

(856)

%

The increase in R&D expenses in the three-month period ended November 30, 2024, compared to the same period in the prior year, was primarily due to an increase in clinical expenses due to initial costs related to the Phase II trial of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer and the classification of clinical employees’ compensation as a research and development cost in the current fiscal year.

The decrease in R&D expenses in the six-month period ended November 30, 2024, compared to the same period in the prior year, was primarily due to a return of clinical expenses related to the settlement of the Company’s litigation with Amarex in July 2024.

The future trend of our R&D expenses is dependent on the costs of any future clinical trials, our decisions regarding which indications on which to focus our future efforts toward the development and study of leronlimab, which may include pre-clinical and clinical studies for oncology and inflammation, as well as efforts to develop a long-acting new or modified therapeutic, the timing and outcomes of such efforts, and the timing of the final close-out of closed studies. The Company projects an increase in clinical expenses beginning in January 2025 due to our start of the Phase II trial of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer.

23

Interest and other income (expense)

Interest and other income (expense) consisted of the following:

Three months ended November 30,

Change

Six months ended November 30,

Change

(in thousands)

2024

    

2023

    

$

    

%

    

2024

    

2023

    

$

    

%

Interest income

142

142

100

$

268

$

268

100

%

Interest on convertible notes payable

$

(1,161)

$

(1,164)

$

3

0

%

(2,326)

$

(2,361)

35

(1)

Amortization of discount on convertible notes

 

(113)

 

(142)

29

20

 

(238)

 

(542)

304

(56)

Amortization of debt issuance costs

(3)

3

100

(369)

369

(100)

Issuance costs for private placement of shares and warrants through placement agent

(906)

906

100

(906)

906

100

Loss on induced conversion

 

 

(636)

636

100

 

(1,180)

 

(2,640)

1,460

(55)

 

Finance charges

 

(9)

 

(891)

882

99

 

(23)

 

(1,803)

1,780

(99)

 

Loss on note extinguishment

(2,406)

2,406

100

(4,490)

4,490

100

Legal settlement

80

80

100

80

80

100

Loss on derivatives

(17)

17

100

(852)

(13)

(839)

6,454

Total interest and other expenses

$

(1,061)

$

(6,165)

$

4,962

(83)

%

$

(4,271)

$

(13,124)

$

8,853

(67)

%

The decrease in interest and other expenses for the three- and six-month periods ended November 30, 2024, compared with the same period in the prior year, was primarily due to the decrease in loss on note extinguishment and finance charges. The decrease in loss on note extinguishment is due to note extinguishments occurring in the prior period. The decrease in finance charges is due to restructuring the balance due to Samsung, which removed any future interest. The decrease in interest and other expenses was offset by an increase in loss on derivatives due to the value of the interest in the Amarex settlement received by investors in the Placement Agent Notes.

Liquidity and Capital Resources

As of November 30, 2024, we had a total of approximately $21.3 million in cash and cash equivalents and approximately $70.6 million in short-term liabilities. We expect to continue to incur operating losses and require a significant amount of capital in the future as we continue to seek approval to commercialize leronlimab. There can be no assurance that future funding will be available to us when needed on terms that are acceptable to us, or at all. We sell securities and incur debt when the terms of such arrangements are deemed acceptable to both parties under then current circumstances and as necessary to fund our current and projected cash needs. As of December 31, 2024, we have approximately 193.4 million shares of common stock available for issuance in new financing transactions.

Since inception, the Company has financed its activities principally from the public and private sale of equity securities as well as with proceeds from issuance of convertible notes and related party notes payable. The Company intends to finance its future operating activities and its working capital needs largely from the sale of equity and debt securities. The sale of equity and convertible debt securities to raise additional capital is likely to result in dilution to stockholders and those securities may have rights senior to those of common shares. If the Company raises funds through the issuance of additional preferred stock, convertible debt securities or other debt or equity financing, the related transaction documents may contain covenants restricting its operations.

During the 2021 fiscal year, the Company entered into long-term convertible notes that are secured by all of our assets (excluding our intellectual property), and include certain restrictive provisions, including limitations on incurring additional indebtedness and future dilutive issuances of securities, any of which could impair our ability to raise additional capital on acceptable terms.

Future third-party funding arrangements may also require the Company to relinquish valuable rights. Additional capital, if available, may not be available on reasonable or non-dilutive terms.

24

Cash and cash equivalents

The Company’s cash and cash equivalents position of approximately $21.3 million and no restricted cash as of November 30, 2024, increased by approximately $18.2 million and decreased by approximately $6.7 million, respectively, when compared to the balance of $3.1 million and $6.7 million, respectively, as of May 31, 2024. This increase was primarily the result of approximately $10.0 million cash received for a legal settlement, the release of the $6.7 million in cash collateral, and approximately $9.7 million in cash provided by financing activities during the six months ended November 30, 2024. Refer to Item 1, Note 2, Summary of Significant Accounting Policies – Going Concern, and the Going Concern discussion below for information regarding concerns about the Company’s ability to continue to fund its operations and satisfy its payment obligations and commitments. A summary of cash flows and changes between the periods presented is as follows:

Six months ended November 30,

Change

(in thousands)

2024

    

2023

    

Net cash provided by (used in):

Net cash provided by (used in) operating activities

$

1,854

$

(6,997)

$

8,851

Net cash provided by/ used in investing activities

$

$

$

Net cash provided by financing activities

$

9,667

$

4,673

$

4,994

Cash provided by operating activities

Net cash provided by operating activities totaled approximately $1.9 million during the six months ended November 30, 2024, representing an improvement of approximately $8.9 million compared to the six months ended November 30, 2023. The increase in the net amount of cash provided by operating activities was due primarily to a legal settlement of approximately $10.0 million. Refer to Note 9, Commitments and Contingencies – Legal Proceedings – Settlement of Amarex Dispute for further discussion.

Cash provided by financing activities

Net cash provided by financing activities totaled approximately $9.7 million during the six months ended November 30, 2024, an increase of approximately $5.0 million compared to the six months ended November 30, 2023. The increase in net cash provided was primarily the result of raising funds through a warrant exchange tender offer during the current period compared to a lower amount raised through private placements of common stock and warrants in the prior period.

Pre-launch inventories

The Company previously capitalized pre-launch inventories which were subsequently charged-off in October 2022 for GAAP accounting purposes due to no longer qualifying for pre-launch inventory capitalization resulting from the withdrawal of the Company’s BLA submission. Work-in-progress and finished drug product inventories continue to be physically maintained, can be used for clinical trials, and can be sold commercially upon regulatory approval if the shelf-lives can be extended as a result of the performance of on-going stability tests. Raw materials continue to be maintained so that they can be used in the future if needed.

25

Convertible debt

April 2, 2021 Convertible Note

On April 2, 2021, we issued a convertible note with a principal amount of $28.5 million resulting in net cash proceeds of $25.0 million, after $3.4 million of debt discount and $0.1 million of offering costs. The note accrues interest daily at a rate of 10% per annum, has a stated conversion price of $10.00 per share, and matures in April 2025. The April 2, 2021 Note required monthly debt reduction payments of $7.5 million for the six months beginning in May 2021, which could also be satisfied by payments on other notes held by the noteholder or its affiliates. Beginning six months after the issuance date, the noteholder may request monthly redemptions of up to $3.5 million. As of November 30, 2024, the outstanding balance of the April 2, 2021 Note, including accrued interest, was approximately $7.9 million.

April 23, 2021 Convertible Note

On April 23, 2021, we issued a convertible note with a principal amount of $28.5 million resulting in net cash proceeds of $25.0 million, after $3.4 million of debt discount and $0.1 million of offering costs. The note accrues interest daily at a rate of 10% per annum, has a stated conversion price of $10.00 per share, and matures in April 2025. Beginning six months after the issuance date, the noteholder may request monthly redemptions of up to $7.0 million. As of November 30, 2024, the outstanding balance of the April 23, 2021 Note, including accrued interest, was approximately $38.4 million.

Common stock

We have 1,750.0 million authorized shares of common stock. The table below summarizes intended uses of common stock.

As of

(in millions)

November 30, 2024

Issuable upon:

Warrant exercises

229.6

Convertible preferred stock and undeclared dividends conversion

38.5

Outstanding stock option exercises

37.5

Reserved for issuance pursuant to future stock-based awards under equity incentive plan

11.5

Reserved and issuable upon conversion of outstanding convertible notes

12.0

Total shares reserved for future uses

329.1

Common stock outstanding

1,223.1

As of November 30, 2024, we had approximately 197.8 million unreserved authorized shares of common stock available for issuance. Our ability to continue to fund our operations depends on our ability to raise capital. The funding necessary for our operations may not be available on acceptable terms, or at all. If we deplete our cash reserves, we may have to discontinue our operations and liquidate our assets. In extreme cases, we could be forced to file for bankruptcy protection.

Off-Balance Sheet Arrangements

As of November 30, 2024, we did not have any off-balance sheet arrangements that have, or are reasonably likely to have, a material effect on our current or future financial condition, results of operations, liquidity, capital expenditures or capital resources.

Contractual Obligations

Refer to Note 3, Accrued Liabilities and Compensation, Note 4, Convertible Instruments and Accrued Interest, and Note 9, Commitments and Contingencies included in Part I, Item 1 of this Form 10-Q, and Notes 5 and 10 in Part II, Item 8 in the 2024 Form 10-K.

26

Legal Proceedings

The Company is a party to various legal proceedings described in Part I, Item 1, Note 9, Commitments and Contingencies – Legal Proceedings of this Form 10-Q. The Company recognizes accruals for such proceedings to the extent a loss is determined to be both probable and reasonably estimable. The best estimate of a loss within a possible range is accrued; however, if no estimate in the range is more probable than another, then the minimum amount in the range is accrued. If it is determined that a material loss is not probable but reasonably possible and the loss or range of loss can be estimated, the possible loss is disclosed.

It is not possible to predict 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, and the outcomes could differ significantly from recognized accruals. 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. As of November 30, 2024, the Company had not recorded any accruals related to the outcomes of the legal matters discussed in this Form 10-Q.

Going Concern

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the 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, except for the six months ended November 30, 2024. Net income of $14.5 million in the six months ended November 30, 2024, resulted from the recovery of approximately $25.0 million in clinical expenses due to the settlement of the Company’s litigation with Amarex, which is a non-recurring event. The Company has an accumulated deficit of approximately $877.1 million as of November 30, 2024. These factors, among several others, raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and 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 performing additional clinical trials and seeking regulatory approval of 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. See also Liquidity and Capital Resources above.

New Accounting Pronouncements

Refer to Part I, Item 1, Note 2, Summary of Significant Accounting Policies – Recent Accounting Pronouncements in this Form 10-Q for the discussion.

Critical Accounting Estimates

This discussion and analysis of the Company’s financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of our financial statements and related disclosures 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 the consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. The Company’s

27

critical accounting estimates are described under the heading Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates in our 2024 Form 10-K.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

There have been no material changes from the information previously reported in Part II, Item 7A of the 2024 Form 10-K.

Item 4. Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act, is (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (2) accumulated and communicated to our management, including our Chief Executive Officer and Interim Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Our management, with the participation of our Chief Executive Officer and Interim Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of November 30, 2024 (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our Chief Executive Officer and Interim Chief Financial Officer concluded, based upon the evaluation described above, that as of November 30, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.

During the quarter ended November 30, 2024, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

28

PART II – Other Information

Item 1. Legal Proceedings

For a description of pending material legal proceedings, please see Note 9, Commitments and Contingencies–Legal Proceedings, of the Notes to Consolidated Financial Statements included in Part I, Item 1 of this Form 10-Q.

Item 1A. Risk Factors

There have been no material changes in the risk factors that were included in our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, which was filed with the SEC on August 15, 2024. You should carefully consider those risk factors in addition to other information in this Form 10-Q.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Issuances of Shares in Convertible Note Exchange Transactions

In October and December 2024, the Company and the holder of its April 23, 2021 Note, in partial satisfaction of the holder’s redemption rights, entered into exchange agreements pursuant to which portions of the original note were partitioned into new notes with an aggregate principal amount of approximately $1.3 million. The new notes were exchanged concurrently with issuance of a total of approximately 8.4 million shares of common stock. The Company relied on the exemption provided by Section 3(a)(9) of the Securities Act in connection with the exchange transaction.

29

Item 6. Exhibits

(a)Exhibits:

Incorporated by Reference

Exhibit
No

 

Description

Filed
Herewith

Form

Exhibit No.

Filing Date

31.1

Rule 13a-14(a) Certification by Principal Executive Officer of the Registrant.

X

31.2

Rule 13a-14(a) Certification by Principal Financial Officer of the Registrant.

X

32

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350.*

X

101.INS

Inline XBRL Instance Document.

X

101.SCH

Inline XBRL Taxonomy Extension Schema Document.

X

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

X

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document.

X

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document.

X

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

X

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

X

*Furnished, not filed.

30

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    

CYTODYN INC.

 

 

(Registrant)

 

 

 

 

Dated: January 14, 2025

 

 

/s/ Jacob Lalezari

 

 

 

Jacob Lalezari

 

 

 

Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

Dated: January 14, 2025

 

 

/s/ Mitchell Cohen 

 

 

 

Mitchell Cohen

 

 

 

Interim Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

31

Exhibit 31.1

Certification of Principal Executive Officer

I, Jacob Lalezari, certify that:

1.      I have reviewed this Quarterly Report on Form 10-Q of CytoDyn Inc.;

2.      Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.      Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

4.      I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a.        designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

b.       designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c.        evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and

d.       disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the registrant’s most-recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

5.      I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

a.        all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

b.       any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

Date: January 14, 2025

      

/s/ Jacob Lalezari

 

 

Jacob Lalezari

 

 

Chief Executive Officer


Exhibit 31.2

Certification of Chief Financial Officer

I, Mitchell Cohen, certify that:

1.       I have reviewed this Quarterly Report on Form 10-Q of CytoDyn Inc.;

2.       Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.       Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

4.       The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a.        designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

b.       designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c.        evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and

d.       disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the registrant’s most-recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

5.       The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

a.        all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

b.       any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

Date: January 14, 2025

      

/s/ Mitchell Cohen

 

 

Mitchell Cohen

 

 

Interim Chief Financial Officer


Exhibit 32

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

In connection with the Quarterly Report of CytoDyn Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended November 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned certify, pursuant to 18 U.S.C. Section 1350, that:

(1)      The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)      The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

/s/ Jacob Lalezari

/s/ Mitchell Cohen

Jacob Lalezari

Mitchell Cohen

Chief Executive Officer

Interim Chief Financial Officer

Date: January 14, 2025

Date: January 14, 2025

A signed original of this written statement required by Section 906 has been provided to CytoDyn Inc. and will be retained by CytoDyn Inc. and furnished to the Securities and Exchange Commission or its staff upon request.


v3.24.4
Cover Page - shares
shares in Thousands
6 Months Ended
Nov. 30, 2024
Dec. 31, 2024
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Nov. 30, 2024  
Securities Act 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 Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   1,228,232
Current Fiscal Year End Date --05-31  
Document Fiscal Year Focus 2025  
Document Fiscal Period Focus Q2  
Entity Central Index Key 0001175680  
Amendment Flag false  
v3.24.4
Consolidated Balance Sheets - USD ($)
$ in Thousands
Nov. 30, 2024
May 31, 2024
Current assets:    
Cash and cash equivalents $ 21,335 $ 3,110
Restricted cash 0 6,704
Prepaid expenses 635 463
Prepaid service fees 663 538
Other receivables (Note 9) 2,000  
Total current assets 24,633 10,815
Other non-current assets 244 321
Total assets 24,877 11,136
Current liabilities:    
Accounts payable 14,244 29,561
Accrued liabilities and compensation 2,767 2,810
Accrued interest on convertible notes 17,553 15,227
Accrued dividends on convertible preferred stock 7,532 6,791
Convertible notes payable, net 28,531 29,793
Total current liabilities 70,627 84,182
Long-term liabilities:    
Operating leases 69 141
Other liabilities (Note 9) 43,571 43,571
Total liabilities 114,267 127,894
Commitments and Contingencies (Note 9)
Stockholders' deficit:    
Common stock, $0.001 par value; 1,750,000 shares authorized; 1,223,517 and 1,059,002 issued, and 1,223,075 and 1,058,559 outstanding at November 30, 2024 and May 31, 2024, respectively 1,224 1,059
Treasury stock, $0.001 par value; 443 shares at November 30, 2024 and May 31, 2024
Additional paid-in capital 786,458 773,714
Accumulated deficit (877,072) (891,531)
Total stockholders' deficit (89,390) (116,758)
Total liabilities and stockholders' deficit 24,877 11,136
Series B Convertible Preferred Stock    
Stockholders' deficit:    
Preferred stock
Series C Convertible Preferred Stock    
Current liabilities:    
Accrued dividends on convertible preferred stock 3,453 3,135
Stockholders' deficit:    
Preferred stock
Series D Convertible Preferred Stock    
Current liabilities:    
Accrued dividends on convertible preferred stock 4,079 3,656
Stockholders' deficit:    
Preferred stock
v3.24.4
Consolidated Balance Sheets (Parenthetical) - $ / shares
shares in Thousands
Nov. 30, 2024
May 31, 2024
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 1,750,000 1,750,000
Common stock, shares issued 1,223,517 1,059,002
Common stock, shares outstanding 1,223,075 1,058,559
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 6
Preferred stock, shares outstanding 6 6
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
v3.24.4
Consolidated Statements of Operations - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 6 Months Ended
Nov. 30, 2024
Nov. 30, 2023
Nov. 30, 2024
Nov. 30, 2023
Operating expenses:        
General and administrative $ 2,294 $ 2,311 $ 3,898 $ 4,999
Research and development 1,409 1,079 (22,637) 2,993
Depreciation 4 8 9 18
Total operating expenses 3,707 3,398 (18,730) 8,010
Operating (loss) gain (3,707) (3,398) 18,730 (8,010)
Interest and other income (expense):        
Interest income 142   268  
Interest expense on convertible notes (1,161) (1,164) (2,326) (2,361)
Amortization of discount on convertible notes (113) (142) (238) (542)
Amortization of debt issuance costs   (3)   (369)
Issuance costs for private placement of shares and warrants through placement agent   (906)   (906)
Loss on induced conversion   (636) (1,180) (2,640)
Finance charges (9) (891) (23) (1,803)
Loss on note extinguishment   (2,406)   (4,490)
Gain on restructuring of payables 80   80  
Loss on derivatives   (17) (852) (13)
Total interest and other expenses (1,061) (6,165) (4,271) (13,124)
(Loss) gain before income taxes (4,768) (9,563) 14,459 (21,134)
Income tax benefit 0 0 0 0
Net (loss) income $ (4,768) $ (9,563) $ 14,459 $ (21,134)
(Loss) income per share:        
Basic (loss) income per share $ 0 $ (0.01) $ 0.01 $ (0.02)
Income (loss) per share, Diluted $ 0 $ (0.01) $ 0.01 $ (0.02)
Weighted average common shares used in calculation of (loss) income per share:        
Weighted average common shares outstanding, Basic 1,221,405 958,988 1,177,988 941,191
Weighted average common shares outstanding, Diluted 1,221,405 958,988 1,204,193 941,191
v3.24.4
Consolidated Statement of Changes in Stockholders' Deficit - USD ($)
shares in Thousands, $ in Thousands
Preferred stock
Common stock
Treasury stock
Additional paid-in capital
Accumulated deficit
Total
Treasury stock, shares     443      
Beginning balance at May. 31, 2023   $ 919   $ 731,270 $ (841,690) $ (109,501)
Beginning balance (shares) at May. 31, 2023 34 919,053        
Issuance of stock for convertible note repayment   $ 8   1,492   1,500
Issuance of stock for convertible note repayment (in shares)   8,661        
Loss on induced conversion       2,004   2,004
Warrants issued in note offering       170   170
Stock issued for compensation   $ 1   154   155
Stock issued for compensation (in shares)   686        
Warrant exercises   $ 3   297   300
Warrant exercises (in shares)   3,000        
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) income         (11,571) (11,571)
Ending balance at Aug. 31, 2023   $ 931   735,441 (853,261) (116,889)
Ending balance (shares) at Aug. 31, 2023 34 931,400        
Beginning balance at May. 31, 2023   $ 919   731,270 (841,690) (109,501)
Beginning balance (shares) at May. 31, 2023 34 919,053        
Net (loss) income           (21,134)
Ending balance at Nov. 30, 2023   $ 971   747,472 (862,824) (114,381)
Ending balance (shares) at Nov. 30, 2023 34 971,286        
Treasury stock, shares     443      
Beginning balance at Aug. 31, 2023   $ 931   735,441 (853,261) (116,889)
Beginning balance (shares) at Aug. 31, 2023 34 931,400        
Issuance of stock for convertible note repayment   $ 4   496   500
Issuance of stock for convertible note repayment (in shares)   3,535        
Loss on induced conversion       636   636
Warrants issued in note offering       10   10
Note conversion   $ 14   4,379   4,393
Note conversion (in shares)   14,339        
Stock issued for compensation   $ 1   97   98
Stock issued for compensation (in shares)   559        
Stock issued for private offering   $ 21   6,307   6,328
Stock issued for private offering (in shares)   21,453        
Dividends accrued on Series C and D convertible preferred stock       (368)   (368)
Stock-based compensation       474   474
Net (loss) income         (9,563) (9,563)
Ending balance at Nov. 30, 2023   $ 971   747,472 (862,824) $ (114,381)
Ending balance (shares) at Nov. 30, 2023 34 971,286        
Treasury stock, shares     443      
Treasury stock, shares     443     443
Beginning balance at May. 31, 2024   $ 1,059   773,714 (891,531) $ (116,758)
Beginning balance (shares) at May. 31, 2024 34 1,059,002        
Issuance of stock for convertible note repayment   $ 9   991   1,000
Issuance of stock for convertible note repayment (in shares)   8,777        
Loss on induced conversion       1,180   1,180
Stock issued for tender offer   $ 152   13,874   14,026
Stock issued for tender offer (in shares)   152,505        
Issuance costs related to stock issued for tender offer       (3,649)   (3,649)
Dividends accrued on Series C and D convertible preferred stock       (372)   (372)
Stock-based compensation       136   136
Net (loss) income         19,227 19,227
Ending balance at Aug. 31, 2024   $ 1,220   785,874 (872,304) (85,210)
Ending balance (shares) at Aug. 31, 2024 34 1,220,284        
Beginning balance at May. 31, 2024   $ 1,059   773,714 (891,531) (116,758)
Beginning balance (shares) at May. 31, 2024 34 1,059,002        
Net (loss) income           14,459
Ending balance at Nov. 30, 2024   $ 1,224   786,458 (877,072) (89,390)
Ending balance (shares) at Nov. 30, 2024 34 1,223,517        
Treasury stock, shares     443      
Beginning balance at Aug. 31, 2024   $ 1,220   785,874 (872,304) (85,210)
Beginning balance (shares) at Aug. 31, 2024 34 1,220,284        
Issuance of stock for convertible note repayment   $ 4   416   420
Issuance of stock for convertible note repayment (in shares)   3,233        
Dividends accrued on Series C and D convertible preferred stock       (369)   (369)
Stock-based compensation       537   537
Net (loss) income         (4,768) (4,768)
Ending balance at Nov. 30, 2024   $ 1,224   $ 786,458 $ (877,072) $ (89,390)
Ending balance (shares) at Nov. 30, 2024 34 1,223,517        
Treasury stock, shares     443     443
v3.24.4
Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Nov. 30, 2024
Nov. 30, 2023
Nov. 30, 2024
Nov. 30, 2023
Cash flows from operating activities:        
Net income (loss) $ (4,768) $ (9,563) $ 14,459 $ (21,134)
Adjustments to reconcile net income (loss) to net cash used in operating activities:        
Depreciation     9 18
Amortization of debt issuance costs   3   369
Issuance costs for private placement of shares and warrants through placement agent   906   906
Amortization of discount on convertible notes 113 142 238 542
Gain on restructuring of payables (80)   (80)  
Loss on derivatives     852 13
Loss on induced conversion   636 1,180 2,640
Loss on note extinguishment   2,406   4,490
Stock-based compensation     673 1,075
Changes in operating assets and liabilities:        
Prepaid expenses and other assets     (2,229) (290)
Accounts payable, accrued expenses, and other liabilities     (13,248) 4,374
Net cash provided by (used in) operating activities     1,854 (6,997)
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     10,377  
Proceeds from sale of common stock and warrants, net of issuance costs       3,016
Proceeds from warrant exercises       300
Proceeds from convertible note and warrant issuances, net of offering costs       1,357
Cash paid for note payable     (710)  
Net cash provided by financing activities     9,667 4,673
Net change in cash and restricted cash     11,521 (2,324)
Cash, cash equivalents, and restricted cash at beginning of period     9,814 9,048
Cash, cash equivalents, and restricted cash at end of period 21,335 6,724 21,335 6,724
Cash, cash equivalents, and restricted cash consisted of the following:        
Cash and cash equivalents 21,335 147 21,335 147
Restricted cash 0 6,577 0 6,577
Total cash, cash equivalents, and restricted cash $ 21,335 $ 6,724 21,335 6,724
Supplemental disclosure:        
Cash paid for interest     23 38
Non-cash investing and financing transactions:        
Derivative liability associated with warrants       80
Issuance of common stock for principal of convertible notes     1,420 2,000
Accrued dividends on Series C and D convertible preferred stock     $ 741 741
Warrants issued to placement agent       413
Note conversion to common stock and warrants       $ 2,295
v3.24.4
Organization
6 Months Ended
Nov. 30, 2024
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, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (“CCR5”).

The Company is currently working to further establish leronlimab via clinical development of its effects on oncology, inflammation and a number of other potential exploratory indications. Historically, the Company has investigated leronlimab as a viral entry inhibitor 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, solid tumors in oncology, COVID-19, Long-COVID, and human immunodeficiency virus (“HIV”) indications where CCR5 is believed to play an integral role in the pathogenesis of disease.

v3.24.4
Summary of Significant Accounting Policies
6 Months Ended
Nov. 30, 2024
Summary of Significant Accounting Policies  
Summary of Significant Accounting Policies

Note 2. Summary of Significant Accounting Policies

Basis of presentation

The unaudited 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, 2024, as amended by Amendment No. 1 on Form 10-K/A (the “2024 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.

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, except for the six months ended November 30, 2024. The Company has an accumulated deficit of approximately $877.1 million as of November 30, 2024. These factors, among others, including the various matters discussed in Note 9, 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 generate 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 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 unaudited consolidated financial statements have been prepared in accordance with GAAP, which 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 discussions with the U.S. Food and Drug Administration (“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 other assumptions that are believed to be reasonable under the circumstances. Significant estimates include, but are not limited to, those relating to stock-based compensation, the assumptions used to value warrants, and warrant modifications. Actual results could differ from these estimates.

Cash and cash equivalents

Cash and cash equivalents are short-term, highly liquid investments with original maturities of three months or less when purchased and comprise bank deposits and money market funds. Our investments in money market funds are measured at fair value on a recurring basis and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The value of the money market fund as of November 30, 2024 was approximately $19.1 million with a zero investment as of May 31, 2024.

Restricted cash

As of November 30, 2024, the Company had no restricted cash. The restricted cash in the prior period was related to cash that was being held as collateral as required in the Amarex Clinical Research L.L.C. (“Amarex”) litigation and was released in full on July 2, 2024, as part of the settlement agreement.

Fair value of financial instruments

In accordance with the prescribed accounting guidance, the Company measured fair value of derivative 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.

Recent Accounting Pronouncements

In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 Accounting Standards Codification (“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.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The standard is intended to improve annual and interim reportable segment disclosure requirements regardless of the number of reporting units, primarily through enhanced disclosure of significant expenses. The amendment requires public entities to disclose significant segment expenses that are regularly provided to the CODM and included with each reported measure of segment profit and loss. The standard is effective for annual periods beginning after December 15, 2023. Early adoption is permitted and the amendments in this update should be applied retrospectively to all periods presented. The Company is currently evaluating the impact of this update on its financial statement disclosures but does not believe it will materially impact the financial statements.

In December 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.

In November 2024, the FASB issued ASU 2024-03, “Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses," which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. The amendments in this ASU will be effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently assessing the potential impacts of adoption on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-04, "Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments," which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion or extinguishment of convertible debt. The new guidance is effective for annual reporting periods beginning after December 15, 2025, and interim periods within those annual periods. The Company is currently evaluating the impact of the standard on its consolidated financial statements and related disclosures.

v3.24.4
Accrued Liabilities and Compensation
6 Months Ended
Nov. 30, 2024
Accrued Liabilities and Compensation  
Accrued Liabilities and Compensation

Note 3. Accrued Liabilities and Compensation

The components of accrued liabilities and compensation are as follows (in thousands):

November 30, 2024

May 31, 2024

Compensation and related expense

$

214

$

208

Legal fees and settlement

111

7

Clinical expense

284

329

License fees

1,875

1,799

Lease payable

141

142

Investor proceeds held in escrow

300

Other liabilities

142

25

Total accrued liabilities

$

2,767

$

2,810

v3.24.4
Convertible Instruments and Accrued Interest
6 Months Ended
Nov. 30, 2024
Convertible Instruments and Accrued Interest  
Convertible Instruments and Accrued Interest

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, 2024

May 31, 2024

(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

$

22

$

$

$

19

$

$

Accrued dividends

$

$

3,453

$

4,079

$

$

3,135

$

3,656

Total shares of common stock if dividends converted

44

6,906

8,158

38

6,270

7,312

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 election 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

The table below presents outstanding convertible notes and accrued interest as of November 30, 2024 and May 31, 2024:

November 30, 2024

May 31, 2024

(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

$

2,831

$

25,869

$

28,700

$

2,831

$

27,369

$

30,200

Less: Unamortized debt discount and issuance costs

(17)

(152)

(169)

(45)

(362)

(407)

Convertible notes payable, net

2,814

25,717

28,531

2,786

27,007

29,793

Accrued interest on convertible notes

5,024

12,529

17,553

4,634

10,593

15,227

Outstanding convertible notes payable, net and accrued interest

$

7,838

$

38,246

$

46,084

$

7,420

$

37,600

$

45,020

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, 2024

$

7,420

$

37,600

$

45,020

Consideration received

Amortization of issuance discount and costs

28

210

238

Interest expense

390

1,936

2,326

Fair market value of shares and warrants exchanged for repayment

(1,600)

(1,600)

Difference between market value of
common shares and reduction of principal

100

100

Outstanding balance at November 30, 2024

$

7,838

$

38,246

$

46,084

April 2, 2021 & April 23, 2021 Notes

Key terms of the outstanding convertible notes (the “Notes”) are as follows:

November 30, 2024

    

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 Notes 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 Notes 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, 2024, in satisfaction of redemptions, the Company and April 23, 2021 Noteholder entered into exchange agreements, pursuant to which the April 23, 2021 Note was partitioned into new notes (the “Partitioned Notes”) with an aggregate principal amount of $1.5 million, which was exchanged concurrently with the issuance of approximately 12.0 million shares of common stock. The outstanding balance of the April 23, 2021 Note was reduced by the Partitioned Notes to a principal amount of $25.9 million. The Company accounted for the Partitioned

Notes and the exchange settlements where the shares exchanged were worth less than principal extinguished as induced conversions, and, accordingly, recorded a non-cash loss on convertible debt induced conversion of approximately $1.2 million for the six months ended November 30, 2024. The Company recognized an approximate $0.1 million gain on restructuring of payables during the six months ended November 30, 2024 for the Partitioned Notes and the exchange settlement where the shares exchanged were worth more than principal extinguished.

As of December 31, 2024, the holders of the Notes waived all provisions 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, 2024.

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 (the “Placement Agent Notes”) for a total principal amount of approximately $2.3 million. 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.

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 of one share plus one 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. The amendment also allowed investors to retain an interest in the Amarex settlement after conversion.

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 6, Private Placements of Common Stock and Warrants – Private placements of common stock and warrants through placement agent in the Company’s 2024 Form 10-K.

Due to the settlement with Amarex in July 2024, the Company owed approximately $0.9 million to Placement Agent Note investors, recorded as a loss on derivatives, of which approximately $0.7 million was paid in the six months ended November 30, 2024. In accordance with the prescribed accounting guidance, the Company measured the fair value of liability classified warrants using fair value hierarchy included in Note 2, Summary of Significant Accounting Policies – Fair Value of Financial Instruments. The Company’s derivative liability is classified within Level 3.

Please refer to Note 5, Convertible Instruments and Accrued Interest, in the Company’s 2024 Form 10-K for additional information.

v3.24.4
Private Placements of Common Stock and Warrants
6 Months Ended
Nov. 30, 2024
Private Placements of Common Stock and Warrants  
Private Placements of Common Stock and Warrants

Note 5. Private Placements of Common Stock and Warrants

Tender offer

On July 19, 2024, the Company closed a tender offer in which warrants to purchase approximately 127.1 million shares of common stock were exercised at a $0.09387 exercise price, resulting in gross proceeds of approximately $11.9 million and net proceeds of approximately $10.4 million. The Company also issued approximately 25.4 million shares of common stock as bonus shares in the tender offer. The Company paid the placement agent a total cash fee of approximately $1.4 million, equal to 13% of the gross proceeds of the offering, as well as repricing all warrants previously issued to the placement agent to $0.09387 per share. In connection with the tender offer, the Company recognized the following issuance costs: $1.4 million in cash paid to the placement agent, $0.1 million in legal fees, a $1.7 million change in fair value of the exercised warrants, and a $0.4 million change in fair value due to repricing the placement agent warrants.

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, 2024

 

361,445

$

0.34

 

4.21

$

2,697

Granted

 

$

 

 

Exercised

 

(127,087)

$

0.09

 

 

Forfeited, expired, and cancelled

 

(4,729)

$

0.37

 

 

Warrants outstanding at November 30, 2024

 

229,629

$

0.26

 

4.08

$

1,269

Warrants outstanding and exercisable at November 30, 2024

 

229,629

$

0.26

 

4.08

$

1,269

v3.24.4
Equity Incentive Plan
6 Months Ended
Nov. 30, 2024
Equity Incentive Plan  
Equity Incentive Plan

Note 6. Equity Incentive Plan

Equity Incentive Plan

As of November 30, 2024, the Company had one active equity incentive plan, the CytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan (the “EIP”). As of November 30, 2024 and May 31, 2024, the EIP covered a total of 66.8 million and 56.3 million shares of common stock, respectively. The “evergreen provision” 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, 2024. 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. Share-based compensation cost is recognized over the period during which the employee or director is required to provide services 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, 2024 and 2023 was $0.5 million and $0.6 million, respectively, and for the six months ended November 30, 2024 and 2023 was $0.7 million and $1.1 million, respectively. Stock-based compensation is recorded in general and administrative and research and development 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, 2024

 

25,849

$

0.60

 

7.77

$

Granted

 

11,675

$

0.14

 

 

Exercised

 

$

 

 

Forfeited, expired, and cancelled

 

(50)

$

0.66

 

 

Options outstanding at November 30, 2024

 

37,474

$

0.46

 

8.10

$

Options outstanding and exercisable at November 30, 2024

 

23,858

$

0.61

 

7.30

$

During the six months ended November 30, 2024 and 2023, stock options for approximately 11.7 million shares and 0.5 million shares, respectively, were granted. Of the current year options, approximately 5.7 million vest over four years, and approximately 6.0 million vest over one year. The prior year options vest when performance conditions are met. 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 $0.12 and $0.23 for the stock options granted in the six months ended November 30, 2024 and 2023, respectively.

v3.24.4
(Loss) Income per Share
6 Months Ended
Nov. 30, 2024
(Loss) Income per Share  
(Loss) Income per Share

Note 7. (Loss) Income per Share

Basic (loss) income per share is computed by dividing the net (loss) income adjusted for preferred stock dividends by the weighted average number of common shares outstanding during the period. Diluted (loss) income per share includes the weighted average common shares outstanding and potentially dilutive common stock equivalents. Basic and diluted (loss) income per share for the three and six months ended November 30, 2024 were calculated as follows:

Three months ended November 30,

Six months ended November 30,

(in thousands, except per share amounts)

2024

    

2023

2024

2023

Numerator:

Net (loss) income

$

(4,768)

$

(9,563)

$

14,459

$

(21,134)

Less: Accrued preferred stock dividends

(369)

(368)

(741)

(741)

Net (loss) income applicable to common stockholders

$

(5,137)

$

(9,931)

$

13,718

$

(21,875)

Denominator:

Basic weighted average common shares outstanding

1,221,405

958,988

1,177,988

941,191

Effect of dilutive securities:

Warrant exercises

26,205

Diluted weighted average common shares outstanding

1,221,405

958,988

1,204,193

941,191

Basic (loss) income per share

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

Diluted (loss) income per share

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

The table below shows the approximate number of shares of common stock issuable upon the exercise, vesting, or conversion of outstanding options, warrants, convertible notes, and convertible preferred stock (including undeclared

dividends) that were not included in the computation of diluted weighted average number of shares of common stock outstanding for the periods presented:

Three and six months ended November 30,

(in thousands)

2024

    

2023

Stock options, warrants, and unvested restricted stock units

240,898

312,956

Convertible notes

12,000

12,000

Convertible preferred stock

38,533

35,558

v3.24.4
Income Taxes
6 Months Ended
Nov. 30, 2024
Income Taxes  
Income Taxes

Note 8. Income Taxes

To determine the Company’s quarterly provision for income taxes, the Company used an estimated annual effective tax rate that is based on expected annual income and statutory tax rates in the various jurisdictions in which the Company operates. Certain significant unusual or infrequently occurring items that are separately reported are separately recognized in the quarter during which they occur and can be a source of variability in the effective tax rate from quarter to quarter.

The Company had no income tax expense for the three and six months ended November 30, 2024 and 2023. The provision for income taxes for the three and six months ended November 30, 2024 and 2023 is based on the Company’s estimated annualized effective tax rate for the fiscal years ending May 31, 2025 and 2024, respectively. For the three and six months ended November 30, 2024, the Company’s recognized effective tax rate differs from the U.S. federal statutory rate due to the Company maintaining a full valuation allowance on its net deferred tax assets, as the Company does not consider it more likely than not that the benefits from the net deferred tax assets will be realized.

v3.24.4
Commitments and Contingencies
6 Months Ended
Nov. 30, 2024
Commitments and Contingencies.  
Commitments and Contingencies

Note 9. Commitments and Contingencies

Commitments with Samsung BioLogics Co., Ltd. (“Samsung”)

On April 3, 2024, the Company and Samsung executed a side letter agreement (the “Side Letter”), wherein the parties reached an agreement for an orderly process for winding down services and a restructuring of the amount payable by the Company to Samsung (the “Total Balance”). The Total Balance due to Samsung, as restructured under the Side Letter, is approximately $43.8 million. Except for a single $250,000 payment that was due and paid before December 31, 2024, the entirety of the Total Balance is conditional, and will only be due and payable, upon the Company achieving a qualifying “Revenue” event, as defined in the Side Letter. Under the Side Letter, the Company has agreed to pay 20% of its qualifying Revenue generated in each calendar year, if any, with such payments to be applied to reduce the Total Balance until it is repaid in full. Interest will not accrue on the Total Balance throughout the prospective repayment period. Revenue is defined in the Side Letter as:

“…the gross revenue generated by Client and its Affiliates, less the following items (if not previously deducted from the amount invoiced): (a) reasonable and customary trade, quantity, and cash discounts actually granted and legally permitted wholesaler chargebacks actually paid or credited by Client and its Affiliates to wholesalers of products; (b) reasonable, customary, and legally permitted rebates and retroactive price reductions actually granted; (c) freight charges for the delivery of products; (d) the portion of the administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers and/or government-mandated Medicare or Medicaid Prescription Drug Plans relating specifically to the product; and (e)

sales, use or excise taxes imposed and actually paid in connection with the sale of products (but excluding any value added taxes or taxes based on income or gross receipts).”

The $250,000 payment that was due and paid before December 31, 2024, is included in accounts payable, and the remaining balance of approximately $43.6 million is included in other long-term liabilities.

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, 2024 and 2023 were approximately $32.0 thousand and $32.0 thousand, respectively and for the six months ended November 30, 2024 and 2023 were approximately $0.1 million and $0.1 million. 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, 2024

May 31, 2024

Assets

Right-of-use asset

$

196

$

264

Liabilities

Current operating lease liability

$

141

$

142

Non-current operating lease liability

 

69

 

141

Total operating lease liability

$

210

$

283

The minimum (base rental) lease payments are expected to be as follows as of November 30, 2024 (in thousands):

Fiscal Year

Amount

2025 - 6 months remaining

$

92

2026

169

Thereafter

Total operating lease payments

261

Less: imputed interest

(51)

Present value of operating lease liabilities

$

210

Supplemental information related to operating leases was as follows:

November 30, 2024

Weighted average remaining lease term

1.4

years

Weighted average discount rate

10.0

%

Commitments with Contract Research Organization

The Company has entered into a project work order for the colorectal cancer clinical trial with our CRO, Syneos Health. In the event of an early termination of the trial, the Company may incur a cancellation fee of up to 5% of the remaining project budget, in addition to any direct, indirect and pass-through costs incurred to wind down the trial.

Distribution and licensing commitments

Refer to Note 10, Commitments and Contingencies, in the 2024 Form 10-K for additional information.

Legal proceedings

As of November 30, 2024, the Company did not record any accruals related to the outcomes of the legal matters described below. It is not 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 Lawsuits

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, as amended (the “Exchange Act”) 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, 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.

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.

On January 29, 2024, two purported stockholders filed a purported derivative lawsuit against certain of the Company’s former officers, certain current and former directors, and the Company as a nominal defendant, in the Delaware Court of Chancery. The complaint generally makes allegations similar to those set forth in the Consolidated Derivative Suit and asserts that the individual defendants breached their fiduciary duties by allowing the Company to make false and misleading statements and by failing to maintain an adequate system of oversight and controls. The complaint also asserts claims against certain individual defendants for breach of fiduciary duty arising from alleged insider trading.

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 suit(s) is/are in an early stage and the claims do not specify an amount of damages, the Company cannot predict the ultimate outcome of the matter(s) 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 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 and will continue to comply with the requests of each agency. In December 2024, a federal jury convicted Mr. Pourhassan and Mr. Kazempour after trial on a number of counts. Mr. Pourhassan and Mr. Kazempour are set to be sentenced in April 2025. The Company cannot predict the ultimate outcome of the DOJ or SEC investigations. 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.

Settlement of Amarex Dispute

On July 2, 2024, the Company and Amarex, the Company’s former CRO, entered into an agreement settling a lawsuit filed by the Company in October 2021 (the “Settlement Agreement”).

The terms of the Settlement Agreement include: (i) the payment by Amarex of $12,000,000 to the Company, of which $10,000,000 was paid on execution of the Settlement Agreement and the balance will be paid on or before July 2, 2025; (ii) the release of the Company’s surety bond posted in the lawsuit and the return of the Company’s cash collateral in the amount of $6,500,000 provided as security to the surety; (iii) the crediting of all amounts claimed by Amarex as due and payable for its CRO services, totaling approximately $14,000,000, reducing the Company’s outstanding balance to zero, with no funds required to be paid by the Company; and (iv) a mutual release of claims, resolving all legal claims between the parties. The effect of the Settlement Agreement is recorded in research and development expense.

v3.24.4
Subsequent Events
6 Months Ended
Nov. 30, 2024
Subsequent Events  
Subsequent Events

Note 10. Subsequent Events

Note conversion

During December 2024, in satisfaction of a redemption, the Company and the April 23, 2021 Noteholder entered into an exchange agreement, pursuant to which a portion of the April 23, 2021 Note was partitioned into a new note with an aggregate principal amount of approximately $0.8 million, which was exchanged concurrently with the issuance of approximately 5.2 million shares of common stock.

v3.24.4
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Nov. 30, 2024
Summary of Significant Accounting Policies  
Basis of presentation

Basis of presentation

The unaudited 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, 2024, as amended by Amendment No. 1 on Form 10-K/A (the “2024 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.

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, except for the six months ended November 30, 2024. The Company has an accumulated deficit of approximately $877.1 million as of November 30, 2024. These factors, among others, including the various matters discussed in Note 9, 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 generate 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 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

Use of estimates

The unaudited consolidated financial statements have been prepared in accordance with GAAP, which 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 discussions with the U.S. Food and Drug Administration (“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 other assumptions that are believed to be reasonable under the circumstances. Significant estimates include, but are not limited to, those relating to stock-based compensation, the assumptions used to value warrants, and warrant modifications. Actual results could differ from these estimates.

Cash and cash equivalents

Cash and cash equivalents

Cash and cash equivalents are short-term, highly liquid investments with original maturities of three months or less when purchased and comprise bank deposits and money market funds. Our investments in money market funds are measured at fair value on a recurring basis and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The value of the money market fund as of November 30, 2024 was approximately $19.1 million with a zero investment as of May 31, 2024.

Restricted cash

Restricted cash

As of November 30, 2024, the Company had no restricted cash. The restricted cash in the prior period was related to cash that was being held as collateral as required in the Amarex Clinical Research L.L.C. (“Amarex”) litigation and was released in full on July 2, 2024, as part of the settlement agreement.

Fair value of financial Instruments

Fair value of financial instruments

In accordance with the prescribed accounting guidance, the Company measured fair value of derivative 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.

Recent Accounting Pronouncements

Recent Accounting Pronouncements

In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 Accounting Standards Codification (“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.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The standard is intended to improve annual and interim reportable segment disclosure requirements regardless of the number of reporting units, primarily through enhanced disclosure of significant expenses. The amendment requires public entities to disclose significant segment expenses that are regularly provided to the CODM and included with each reported measure of segment profit and loss. The standard is effective for annual periods beginning after December 15, 2023. Early adoption is permitted and the amendments in this update should be applied retrospectively to all periods presented. The Company is currently evaluating the impact of this update on its financial statement disclosures but does not believe it will materially impact the financial statements.

In December 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.

In November 2024, the FASB issued ASU 2024-03, “Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses," which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. The amendments in this ASU will be effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently assessing the potential impacts of adoption on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-04, "Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments," which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion or extinguishment of convertible debt. The new guidance is effective for annual reporting periods beginning after December 15, 2025, and interim periods within those annual periods. The Company is currently evaluating the impact of the standard on its consolidated financial statements and related disclosures.

v3.24.4
Accrued Liabilities and Compensation (Tables)
6 Months Ended
Nov. 30, 2024
Accrued Liabilities and Compensation  
Schedule of components of accrued liabilities and compensation

The components of accrued liabilities and compensation are as follows (in thousands):

November 30, 2024

May 31, 2024

Compensation and related expense

$

214

$

208

Legal fees and settlement

111

7

Clinical expense

284

329

License fees

1,875

1,799

Lease payable

141

142

Investor proceeds held in escrow

300

Other liabilities

142

25

Total accrued liabilities

$

2,767

$

2,810

v3.24.4
Convertible Instruments and Accrued Interest (Tables)
6 Months Ended
Nov. 30, 2024
Convertible Instruments and Accrued Interest  
Schedule of information on dividends of convertible preferred stock

November 30, 2024

May 31, 2024

(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

$

22

$

$

$

19

$

$

Accrued dividends

$

$

3,453

$

4,079

$

$

3,135

$

3,656

Total shares of common stock if dividends converted

44

6,906

8,158

38

6,270

7,312

Schedule of outstanding balances of convertible notes and accrued interest

November 30, 2024

May 31, 2024

(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

$

2,831

$

25,869

$

28,700

$

2,831

$

27,369

$

30,200

Less: Unamortized debt discount and issuance costs

(17)

(152)

(169)

(45)

(362)

(407)

Convertible notes payable, net

2,814

25,717

28,531

2,786

27,007

29,793

Accrued interest on convertible notes

5,024

12,529

17,553

4,634

10,593

15,227

Outstanding convertible notes payable, net and accrued interest

$

7,838

$

38,246

$

46,084

$

7,420

$

37,600

$

45,020

Schedule of reconciliation of changes to outstanding balance of convertible notes, including accrued interest

(in thousands)

April 2, 2021 Note

April 23, 2021 Note

Total

Outstanding balance at May 31, 2024

$

7,420

$

37,600

$

45,020

Consideration received

Amortization of issuance discount and costs

28

210

238

Interest expense

390

1,936

2,326

Fair market value of shares and warrants exchanged for repayment

(1,600)

(1,600)

Difference between market value of
common shares and reduction of principal

100

100

Outstanding balance at November 30, 2024

$

7,838

$

38,246

$

46,084

Summary of key terms of the outstanding convertible notes

November 30, 2024

    

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

v3.24.4
Private Placements of Common Stock and Warrants (Tables)
6 Months Ended
Nov. 30, 2024
Private Placements of Common Stock and Warrants  
Schedule of warrant activity

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, 2024

 

361,445

$

0.34

 

4.21

$

2,697

Granted

 

$

 

 

Exercised

 

(127,087)

$

0.09

 

 

Forfeited, expired, and cancelled

 

(4,729)

$

0.37

 

 

Warrants outstanding at November 30, 2024

 

229,629

$

0.26

 

4.08

$

1,269

Warrants outstanding and exercisable at November 30, 2024

 

229,629

$

0.26

 

4.08

$

1,269

v3.24.4
Equity Incentive Plan (Tables)
6 Months Ended
Nov. 30, 2024
Equity Incentive Plan  
Schedule of stock option activity

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, 2024

 

25,849

$

0.60

 

7.77

$

Granted

 

11,675

$

0.14

 

 

Exercised

 

$

 

 

Forfeited, expired, and cancelled

 

(50)

$

0.66

 

 

Options outstanding at November 30, 2024

 

37,474

$

0.46

 

8.10

$

Options outstanding and exercisable at November 30, 2024

 

23,858

$

0.61

 

7.30

$

v3.24.4
(Loss) Income per Share (Tables)
6 Months Ended
Nov. 30, 2024
(Loss) Income per Share  
Schedule of reconciliation of the numerators and denominators of basic and diluted net (loss) income per share

Three months ended November 30,

Six months ended November 30,

(in thousands, except per share amounts)

2024

    

2023

2024

2023

Numerator:

Net (loss) income

$

(4,768)

$

(9,563)

$

14,459

$

(21,134)

Less: Accrued preferred stock dividends

(369)

(368)

(741)

(741)

Net (loss) income applicable to common stockholders

$

(5,137)

$

(9,931)

$

13,718

$

(21,875)

Denominator:

Basic weighted average common shares outstanding

1,221,405

958,988

1,177,988

941,191

Effect of dilutive securities:

Warrant exercises

26,205

Diluted weighted average common shares outstanding

1,221,405

958,988

1,204,193

941,191

Basic (loss) income per share

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

Diluted (loss) income per share

$

(0.00)

$

(0.01)

$

0.01

$

(0.02)

Schedule of securities excluded from computation of earnings per share

Three and six months ended November 30,

(in thousands)

2024

    

2023

Stock options, warrants, and unvested restricted stock units

240,898

312,956

Convertible notes

12,000

12,000

Convertible preferred stock

38,533

35,558

v3.24.4
Commitments and Contingencies (Tables)
6 Months Ended
Nov. 30, 2024
Commitments and Contingencies.  
Schedule of operating lease balances

(in thousands)

November 30, 2024

May 31, 2024

Assets

Right-of-use asset

$

196

$

264

Liabilities

Current operating lease liability

$

141

$

142

Non-current operating lease liability

 

69

 

141

Total operating lease liability

$

210

$

283

Schedule of the minimum (base rental) lease payments

The minimum (base rental) lease payments are expected to be as follows as of November 30, 2024 (in thousands):

Fiscal Year

Amount

2025 - 6 months remaining

$

92

2026

169

Thereafter

Total operating lease payments

261

Less: imputed interest

(51)

Present value of operating lease liabilities

$

210

Schedule of supplemental information relating to operating leases

November 30, 2024

Weighted average remaining lease term

1.4

years

Weighted average discount rate

10.0

%

v3.24.4
Summary of Significant Accounting Policies (Details) - USD ($)
$ in Thousands
Nov. 30, 2024
May 31, 2024
Nov. 30, 2023
Summary of Significant Accounting Policies      
Accumulated deficit $ (877,072) $ (891,531)  
Money market fund value 19,100    
Restricted cash $ 0 $ 6,704 $ 6,577
v3.24.4
Accrued Liabilities and Compensation (Details) - USD ($)
$ in Thousands
Nov. 30, 2024
May 31, 2024
Accrued Liabilities and Compensation    
Compensation and related expense $ 214 $ 208
Legal fees and settlement 111 7
Clinical expense 284 329
License fees 1,875 1,799
Lease payable 141 142
Investor proceeds held in escrow   300
Other liabilities 142 25
Total accrued liabilities $ 2,767 $ 2,810
v3.24.4
Convertible Instruments and Accrued Interest - Preferred stock (Details)
$ / shares in Units, shares in Thousands, $ in Thousands
6 Months Ended 12 Months Ended
Nov. 30, 2024
USD ($)
$ / shares
shares
May 31, 2024
USD ($)
$ / shares
shares
Class of Stock    
Accrued dividends | $ $ 7,532 $ 6,791
Preferred stock, par value | $ / shares $ 0.001 $ 0.001
Accumulated deficit | $ $ (877,072) $ (891,531)
Series B Preferred Stock [Member]    
Class of Stock    
Shares of preferred stock outstanding 19 19
Common stock conversion rate 10 10
Total shares of common stock if converted 190 190
Undeclared dividends | $ $ 22 $ 19
Total shares of common stock if dividends converted 44 38
Preferred stock, liquidation preference per share ($ per share) | $ / shares $ 5  
Preferred stock, par value | $ / shares $ 0.001 $ 0.001
Series C Preferred Stock [Member]    
Class of Stock    
Shares of preferred stock outstanding 6 6
Common stock conversion rate 2,000 2,000
Total shares of common stock if converted 12,670 12,670
Accrued dividends | $ $ 3,453 $ 3,135
Total shares of common stock if dividends converted 6,906 6,270
Preferred stock, par value | $ / shares $ 0.001 $ 0.001
Series D Preferred Stock [Member]    
Class of Stock    
Shares of preferred stock outstanding 9 9
Common stock conversion rate 1,250 1,250
Total shares of common stock if converted 10,565 10,565
Accrued dividends | $ $ 4,079 $ 3,656
Total shares of common stock if dividends converted 8,158 7,312
Preferred stock, par value | $ / shares $ 0.001 $ 0.001
Series C and Series D Convertible Preferred Stock    
Class of Stock    
Preferred stock, liquidation preference per share ($ per share) | $ / shares $ 1,000  
v3.24.4
Convertible Instruments and Accrued Interest - Outstanding Balance (Details) - USD ($)
$ in Thousands
Nov. 30, 2024
May 31, 2024
Debt Instrument    
Convertible notes payable outstanding principal $ 28,700 $ 30,200
Less: Unamortized debt discount and issuance costs (169) (407)
Convertible notes payable, net 28,531 29,793
Accrued interest on convertible notes 17,553 15,227
Outstanding convertible notes payable, net and accrued interest 46,084 45,020
Long-term Convertible Note - April 2, 2021 Note    
Debt Instrument    
Convertible notes payable outstanding principal 2,831 2,831
Less: Unamortized debt discount and issuance costs (17) (45)
Convertible notes payable, net 2,814 2,786
Accrued interest on convertible notes 5,024 4,634
Outstanding convertible notes payable, net and accrued interest 7,838 7,420
Long-term Convertible Note - April 23, 2021 Note    
Debt Instrument    
Convertible notes payable outstanding principal 25,869 27,369
Less: Unamortized debt discount and issuance costs (152) (362)
Convertible notes payable, net 25,717 27,007
Accrued interest on convertible notes 12,529 10,593
Outstanding convertible notes payable, net and accrued interest $ 38,246 $ 37,600
v3.24.4
Convertible Instruments and Accrued Interest - Components (Details)
$ in Thousands
6 Months Ended
Nov. 30, 2024
USD ($)
Debt Instrument  
Outstanding balance, beginning $ 45,020
Amortization of issuance discount and costs 238
Interest expense 2,326
Fair market value of shares and warrants exchanged for repayment (1,600)
Difference between market value of common shares and reduction of principal 100
Outstanding balance, ending 46,084
Long-term Convertible Note - April 2, 2021 Note  
Debt Instrument  
Outstanding balance, beginning 7,420
Amortization of issuance discount and costs 28
Interest expense 390
Outstanding balance, ending 7,838
Long-term Convertible Note - April 23, 2021 Note  
Debt Instrument  
Outstanding balance, beginning 37,600
Amortization of issuance discount and costs 210
Interest expense 1,936
Fair market value of shares and warrants exchanged for repayment (1,600)
Difference between market value of common shares and reduction of principal 100
Outstanding balance, ending $ 38,246
v3.24.4
Convertible Instruments and Accrued Interest - Convertible Note - April 2, 2021 & April 23, 2021 Note (Details) - USD ($)
$ / shares in Units, $ in Thousands, shares in Millions
3 Months Ended 6 Months Ended
Nov. 30, 2024
Nov. 30, 2024
May 31, 2024
Apr. 23, 2021
Apr. 02, 2021
Debt Instrument          
Aggregate principal amount $ 28,700 $ 28,700 $ 30,200    
Gain on restructuring of payables $ 80 $ 80      
Convertible Note - April 2, 2021 Note          
Debt Instrument          
Convertible notes, interest rate 10.00% 10.00%      
Conversion price per share $ 10 $ 10      
Number of days of notice to be given for conversion of notes into common stock   5 days      
Shares reserved         6.0
Aggregate principal amount $ 2,831 $ 2,831 2,831    
Partitioned Notes          
Debt Instrument          
Convertible note, aggregate principal 1,500 1,500      
Convertible Note - April 23, 2021 Note          
Debt Instrument          
Convertible note, aggregate principal $ 25,900 $ 25,900      
Convertible notes, interest rate 10.00% 10.00%      
Conversion price per share $ 10 $ 10      
Shares reserved       6.0  
Conversion of Series C preferred stock to common stock (in shares)   12.0      
Aggregate principal amount $ 25,869 $ 25,869 $ 27,369    
Loss on induced conversion   $ 1,200      
v3.24.4
Convertible Instruments and Accrued Interest - Convertible Note - Placement Agent Notes and Short-term Notes (Details)
$ / shares in Units, $ in Thousands, shares in Millions
1 Months Ended 3 Months Ended 6 Months Ended
Jul. 19, 2024
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
item
$ / shares
Nov. 30, 2023
USD ($)
Jun. 30, 2023
USD ($)
$ / shares
Nov. 30, 2024
USD ($)
Nov. 30, 2023
USD ($)
Jun. 30, 2022
$ / shares
Debt Instrument              
Warrants to purchase common shares, shares | shares 127.1            
Class of warrants, exercise price | $ / shares $ 0.09387 $ 0.306   $ 0.306     $ 0.5
Stock offering costs $ 1,400            
Number of share in a unit | item   1          
Number of warrant in a unit | item   1          
Intraday volume weighted average price, Percentage   90.00%          
Loss on note extinguishment     $ (2,406)     $ (4,490)  
Loss on derivatives     $ (17)   $ (852) $ (13)  
Placement Agent Notes              
Debt Instrument              
Convertible notes, interest rate   6.00%   6.00%      
Debt instrument term       18 months      
Convertible note, aggregate principal   $ 2,300   $ 2,300      
Loss on derivatives         900    
Payment made to placement agent         $ 700    
v3.24.4
Private Placements of Common Stock and Warrants - Private Placement of Shares of Common Stock and Warrants (Details) - USD ($)
$ / shares in Units, $ in Thousands, shares in Millions
6 Months Ended
Jul. 19, 2024
Nov. 30, 2023
Jun. 30, 2023
Jun. 30, 2022
Private Placements of Common Stock and Warrants        
Exercise price of share $ 0.09387   $ 0.306 $ 0.5
Legal fees $ 100      
Fair value of exercised warrants 1,700      
Fair value due to repricing $ 400      
Shares issued during the period new issues shares 25.4      
Common stock warrants to purchase shares 127.1      
Placement agent fees and expenses $ 1,400      
Percentage of gross proceeds 13.00%      
Proceeds from warrant exercises $ 11,900 $ 300    
Net proceeds from warrant exercises $ 10,400      
v3.24.4
Private Placements of Common Stock and Warrants - Warrants Activity (Details) - USD ($)
$ / shares in Units, $ in Thousands
6 Months Ended 12 Months Ended
Nov. 30, 2024
May 31, 2024
Private Placements of Common Stock and Warrants    
Warrants outstanding beginning of period 361,445  
Exercised (127,087)  
Forfeited, expired, and cancelled (4,729)  
Warrants outstanding at end of period 229,629 361,445
Warrants outstanding and exercisable 229,629  
Outstanding at the beginning of the year (in dollars per share) $ 0.34  
Exercised (in dollars per share) 0.09  
Forfeited, expired, and cancelled (in dollars per share) 0.37  
Outstanding at the end of the year (in dollars per share) 0.26 $ 0.34
Warrants outstanding and exercisable (in dollars per share) $ 0.26  
Weighted average remaining contractual life in years 4 years 29 days 4 years 2 months 15 days
Weighted average remaining contractual life in years outstanding and exercisable 4 years 29 days  
Aggregate intrinsic value outstanding of beginning $ 2,697  
Aggregate intrinsic value outstanding of end period 1,269 $ 2,697
Aggregate intrinsic value outstanding and exercisable $ 1,269  
v3.24.4
Equity Incentive Plan - Options, RSUs, PSUs (Details)
shares in Millions, $ in Millions
3 Months Ended 6 Months Ended
Jun. 01, 2024
Nov. 30, 2024
USD ($)
shares
Nov. 30, 2023
USD ($)
Nov. 30, 2024
USD ($)
plan
shares
Nov. 30, 2023
USD ($)
May 31, 2024
shares
Share-based Compensation            
Number of active plans | plan       1    
Selling, General and Administrative Expenses            
Share-based Compensation            
Stock based compensation | $   $ 0.5 $ 0.6 $ 0.7 $ 1.1  
2012 Equity Incentive Plan            
Share-based Compensation            
Number of shares authorized for issuance | shares   66.8   66.8   56.3
Percentage of share outstanding 1.00%          
v3.24.4
Equity Incentive Plan - Stock options (Details) - $ / shares
shares in Thousands
6 Months Ended 12 Months Ended
Nov. 30, 2024
Nov. 30, 2023
May 31, 2024
Additional Information      
Stock options grant date fair value $ 0.12 $ 0.23  
Stock Options      
Number of shares      
Options outstanding at the beginning of the period 25,849    
Granted 11,675    
Forfeited, expired, and cancelled (50)    
Options outstanding at the end of the period 37,474   25,849
Options outstanding and exercisable (in shares) 23,858    
Weighted average exercise price      
Options outstanding at the beginning of the period (in dollars per share) $ 0.6    
Granted 0.14    
Forfeited, expired, and cancelled 0.66    
Options outstanding at the end of the period (in dollars per share) 0.46   $ 0.6
Options outstanding and exercisable $ 0.61    
Additional Information      
Weighted average remaining contractual life in years 8 years 1 month 6 days   7 years 9 months 7 days
Weighted average remaining contractual life in years exercisable 7 years 3 months 18 days    
Stock option granted, Shares 11,700 500  
Stock Options | Tranche One      
Additional Information      
Stock option vested, Shares 5,700    
Award vesting period 4 years    
Stock Options | Tranche Two      
Additional Information      
Stock option vested, Shares 6,000    
Award vesting period 1 year    
v3.24.4
(Loss) Income per Share - Summary of Reconciliation of Net Income (Loss) Per Share (Details) - USD ($)
$ / shares in Units, shares in Thousands, $ in Thousands
3 Months Ended 6 Months Ended
Nov. 30, 2024
Aug. 31, 2024
Nov. 30, 2023
Aug. 31, 2023
Nov. 30, 2024
Nov. 30, 2023
Numerator:            
Net (loss) income $ (4,768) $ 19,227 $ (9,563) $ (11,571) $ 14,459 $ (21,134)
Less: Accrued preferred stock dividends (369)   (368)   (741) (741)
Net (loss) income applicable to common stockholders $ (5,137)   $ (9,931)   $ 13,718 $ (21,875)
Denominator:            
Basic weighted average common shares outstanding 1,221,405   958,988   1,177,988 941,191
Effect of dilutive securities:            
Warrant exercises         26,205  
Diluted weighted average common shares outstanding 1,221,405   958,988   1,204,193 941,191
Basic (loss) income per share $ 0   $ (0.01)   $ 0.01 $ (0.02)
Diluted (loss) income per share $ 0   $ (0.01)   $ 0.01 $ (0.02)
v3.24.4
(Loss) Income per Share - Summary of Weighted Average Number of Shares of Common Stock Outstanding (Details) - shares
shares in Thousands
3 Months Ended 6 Months Ended
Nov. 30, 2024
Nov. 30, 2023
Nov. 30, 2024
Nov. 30, 2023
Stock options, warrants, and unvested restricted stock units        
Antidilutive Securities Excluded from Computation of Earnings Per Share        
Antidilutive securities excluded from computation of income (loss) per common share 240,898 312,956 240,898 312,956
Convertible notes        
Antidilutive Securities Excluded from Computation of Earnings Per Share        
Antidilutive securities excluded from computation of income (loss) per common share 12,000 12,000 12,000 12,000
Convertible preferred stock        
Antidilutive Securities Excluded from Computation of Earnings Per Share        
Antidilutive securities excluded from computation of income (loss) per common share 38,533 35,558 38,533 35,558
v3.24.4
Income Taxes (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Nov. 30, 2024
Nov. 30, 2023
Nov. 30, 2024
Nov. 30, 2023
Income Taxes        
Income tax expense $ 0 $ 0 $ 0 $ 0
v3.24.4
Commitments and Contingencies (Details) - USD ($)
6 Months Ended
Apr. 03, 2024
Nov. 30, 2024
Commitments and Contingencies    
Cancellation fee, percentage   5.00%
Side Letter Agreement With Samsung    
Commitments and Contingencies    
Past due balance $ 43,800,000  
Contractual obligation, non contingent amount $ 250,000 $ 250,000
Contractual obligation, percentage of qualifying revenue agreed to pay 20.00%  
Amount of contractual obligation included in other liabilities   $ 43,600,000
v3.24.4
Commitments and Contingencies - Summary of Operating Lease Balances (Details) - USD ($)
3 Months Ended 6 Months Ended
Nov. 30, 2024
Nov. 30, 2023
Nov. 30, 2024
Nov. 30, 2023
May 31, 2024
Commitments and Contingencies.          
Operating lease costs $ 32,000 $ 32,000 $ 100,000 $ 100,000  
Right-of-use asset $ 196,000   $ 196,000   $ 264,000
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 $ 141,000   $ 141,000   $ 142,000
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 $ 69,000   $ 69,000   $ 141,000
Total operating lease liability $ 210,000   $ 210,000   $ 283,000
v3.24.4
Commitments and Contingencies - Summary of Minimum (Base Rental) Lease Payments (Details) - USD ($)
$ in Thousands
Nov. 30, 2024
May 31, 2024
Fiscal Year    
2025 - 6 months remaining $ 92  
2026 169  
Total operating lease payments 261  
Less: imputed interest (51)  
Total operating lease liability $ 210 $ 283
v3.24.4
Commitments and Contingencies - Supplemental Information Related to Operating Leases (Details)
Nov. 30, 2024
Commitments and Contingencies.  
Weighted average remaining lease term 1 year 4 months 24 days
Weighted average discount rate 10.00%
v3.24.4
Commitments and Contingencies - Settlement of Amarex Dispute (Details) - Amarex Dispute
Jul. 02, 2024
USD ($)
Commitments and Contingencies  
Amount awarded from other party $ 12,000,000
Payment on execution of settlement agreement 10,000,000
Cash collateral returned as security to the surety 6,500,000
Amount of setoff of settlement agreement $ 14,000,000
v3.24.4
Subsequent Events (Details) - Subsequent Event - Long-term Convertible Note - April 23, 2021 Note
shares in Millions, $ in Millions
1 Months Ended
Dec. 31, 2024
USD ($)
shares
Subsequent Events  
Convertible note, aggregate principal | $ $ 0.8
Shares exchanged | shares 5.2

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