Quarterly Report for Quarter Ending August 31, 2024 (Form 10-Q)

Table of Contents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

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

For the quarterly period ended August 31, 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 September 30, 2024, there were 1,219,842thousand shares outstanding of the registrant's $0.001 par value common stock.

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Table of Contents

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TABLE OF CONTENTS

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​	PAGE
PART IFinancial Information	3
​	ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS	3
​	ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	19
​	ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	26
​	ITEM 4. CONTROLS AND PROCEDURES	26
PART IIOther Information	28
​	ITEM 1. LEGAL PROCEEDINGS	28
​	ITEM 1A. RISK FACTORS	28
​	ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS	28
​	ITEM 6. EXHIBITS	29

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2

Table of Contents

PART I. Financial Information

Item 1. Consolidated Financial Statements

CytoDyn Inc.

Consolidated Balance Sheets

(Unaudited, in thousands, except par value)

​

​	​	​	​	​	​	​
​	​	​	August 31, 2024	​		May 31, 2024
Assets		​	​	​	​	​
Current assets:		​	​		​
Cash	​	$	24,921	​	$	3,110
Restricted cash	​		-	​		6,704
Prepaid expenses	​		570	​		463
Prepaid service fees	​		247	​		538
Other receivables (Note 9)	​	​	2,000	​	​	-
Total current assets	​		27,738	​		10,815
Other non-current assets	​		283	​		321
Total assets	​	$	28,021	​	$	11,136
Liabilities and Stockholders' Deficit	​			​
Current liabilities:	​			​
Accounts payable	​	$	14,159	​	$	29,561
Accrued liabilities and compensation	​		2,923	​		2,810
Accrued interest on convertible notes	​		16,392	​		15,227
Accrued dividends on convertible preferred stock	​		7,163	​		6,791
Convertible notes payable, net	​		28,918	​		29,793
Total current liabilities	​		69,555	​		84,182
Operating leases	​		105	​		141
Other liabilities (Note 9)	​	​	43,571	​	​	43,571
Total liabilities	​		113,231	​		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 August 31, 2024 and May 31, 2024	​		-	​		-
Series C convertible preferred stock, $0.001 par value; 8 authorized; 6 issued and outstanding at August 31, 2024 and May 31, 2024	​		-	​		-
Series D convertible preferred stock, $0.001 par value; 12 authorized; 9 issued and outstanding at August 31, 2024 and May 31, 2024	​		-	​		-
Common stock, $0.001 par value; 1,750,000 shares authorized; 1,220,284 and 1,059,002 issued, and 1,219,841 and 1,058,559 outstanding at August 31, 2024 and May 31, 2024, respectively	​		1,220	​		1,059
Treasury stock, $0.001 par value; 443 shares at August 31, 2024 and May 31, 2024	​	​	-	​	​	-
Additional paid-in capital	​		785,874	​		773,714
Accumulated deficit	​		(872,304)	​		(891,531)
Total stockholders' deficit	​		(85,210)	​		(116,758)
Total liabilities and stockholders' deficit	​	$	28,021	​	$	11,136

​

See accompanying notes to consolidated financial statements.

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Table of Contents

CytoDyn Inc.

Consolidated Statements of Operations

(Unaudited, in thousands, except per share data)

​

​	​	​	​	​	​	​
​	​	Three months ended August 31,
​		2024		2023
Operating expenses:		​			​
General and administrative	​	$	1,604	​	$	2,688
Research and development	​		(24,046)	​		1,914
Depreciation	​		5	​		10
Total operating expenses	​		(22,437)	​		4,612
Operating gain (loss)	​		22,437	​		(4,612)
Interest and other income (expense):	​	​	​	​	​	​
Interest income	​	​	126	​	​	-
Interest on convertible notes	​		(1,165)	​		(1,197)
Amortization of discount on convertible notes	​	​	(125)	​	​	(400)
Amortization of debt issuance costs	​		-	​		(366)
Loss on induced conversion	​	​	(1,180)	​	​	(2,004)
Finance charges	​		(14)	​		(912)
Loss on note extinguishment	​		-	​		(2,084)
(Loss) gain on derivatives	​	​	(852)	​	​	4
Total interest and other expenses	​		(3,210)	​		(6,959)
Gain (loss) before income taxes	​		19,227	​		(11,571)
Income tax benefit	​		-	​		-
Net income (loss)	​	$	19,227	​	$	(11,571)
​	​	​	​	​	​	​
Income (Loss) per share:	​	​	​	​	​	​
Basic	​	$	0.02	​	$	(0.01)
Diluted	​	$	0.02	​	$	(0.01)
​	​	​	​	​	​	​
Weighted average common shares used in calculation of income (loss) per share:	​	​	​	​	​	​
Basic	​	​	1,135,043	​	​	923,587
Diluted	​	​	1,198,287	​	​	923,587

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See accompanying notes to consolidated financial statements.

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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)

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

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)

​

See accompanying notes to consolidated financial statements.

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CytoDyn Inc.

Consolidated Statements of Cash Flows

(Unaudited, in thousands)

​

​	​	​	​	​	​	​
​	​	Three months ended August 31,
​		2024		2023
​	​	​	​	​	​	​
Cash flows from operating activities:		​			​	​
Net income (loss)	​	$	19,227	​	$	(11,571)
Adjustments to reconcile net income (loss) to net cash used in operating activities:	​			​
Amortization and depreciation	​		5	​		10
Amortization of debt issuance costs	​		-	​		366
Amortization of discount on convertible notes	​		125	​		400
Loss (gain) on derivatives	​	​	852	​	​	(4)
Loss on induced conversion	​	​	1,180	​	​	2,004
Loss on note extinguishment	​		-	​		2,084
Stock-based compensation	​		136	​		503
Changes in operating assets and liabilities:	​		​	​
Prepaid expenses and other assets	​	​	(1,783)	​	​	(1,605)
Accounts payable, accrued expenses, and other liabilities	​		(14,302)	​		3,318
Net cash provided by (used in) operating activities	​		5,440	​		(4,495)
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	​		-	​		2,575
Proceeds from warrant exercises	​		-	​		300
(Cash paid for) proceeds from note payable	​	​	(710)	​	​	1,144
Net cash provided by financing activities	​		9,667	​		4,019
Net change in cash and restricted cash	​		15,107	​		(476)
Cash and restricted cash at beginning of period	​		9,814	​		9,048
Cash and restricted cash at end of period	​	$	24,921	​	$	8,572
Cash and restricted cash consisted of the following:	​	​	​	​	​	​
Cash	​	$	24,921	​	$	2,034
Restricted cash	​	​	-	​	​	6,538
Total cash and restricted cash	​	$	24,921	​	$	8,572
Supplemental disclosure:	​	​	​	​	​	​
Cash paid for interest	​	$	45	​	$	24
Non-cash investing and financing transactions:	​			​
Derivative liability associated with warrants	​	$	-	​	$	83
Issuance of common stock for principal of convertible notes	​	$	1,000	​	$	1,500
Accrued dividends on Series C and D convertible preferred stock	​	$	372	​	$	373
Warrants issued to placement agent	​	$	-	​	$	413
Note conversion to common stock and warrants	​	$	-	​	$	2,295

​

​

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See accompanying notes to consolidated financial statements.

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CYTODYN INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

AS OF AUGUST 31, 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 chronic inflammation, oncology, and a number of other potential exploratory indications. Historically, the Company has investigated leronlimab as a viral entry inhibitor for treatment of human immunodeficiency virus ("HIV"), believed to competitively bind to the N-terminus and second extracellular loop of the CCR5 receptor. For immunology, the CCR5 receptor is believed to be implicated in immune-mediated illnesses such as metabolic dysfunction-associated steatohepatitis ("MASH"), replacement for the term nonalcoholic steatohepatitis ("NASH"). Leronlimab is being or has been studied in MASH, solid tumors in oncology, COVID-19, Long-COVID, and 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 current period. The Company has an accumulated deficit of approximately $872.3 million as of August 31, 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

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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/or 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.

Restricted cash

As of August 31, 2024, the Company had no restricted cash. The restricted cash in the prior period was related to cash that was being held as collateral in connection with a surety bond that was posted 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

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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("ASU 2023-07"). 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.

On December 14, 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. The ASU is effective for annual periods beginning after December 15, 2024, and allows for adoption on a prospective basis, with a retrospective option. The Company is currently evaluating the effect of this update on its consolidated financial statements and related disclosures.

Note 3. Accrued Liabilities and Compensation

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

​	​	​	​	​	​	​
​	​	​	August 31, 2024	​	​	May 31, 2024
Compensation and related expense	​	$	362	​	$	208
Legal fees and settlement	​	​	101	​	​	7
Clinical expense	​	​	143	​	​	329
License fees	​	​	2,033	​	​	1,799
Lease payable	​	​	142	​	​	142
Investor proceeds held in escrow	​	​	-	​	​	300
Other liabilities	​	​	142	​	​	25
Total accrued liabilities	​	$	2,923	​	$	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.

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

August 31, 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

​

$

21

​

$

-

​

$

-

​

$

19

​

$

-

​

$

-

Accrued dividends

​

$

-

​

$

3,295

​

$

3,868

​

$

-

​

$

3,135

​

$

3,656

Total shares of common stock if dividends converted

​

​

42

​

​

6,590

​

​

7,736

​

​

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

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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 August 31, 2024 and May 31, 2024:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

August 31, 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

​

$

26,369

​

$

29,200

​

$

2,831

​

$

27,369

​

$

30,200

Less: Unamortized debt discount and issuance costs

​

​

(30)

​

​

(252)

​

​

(282)

​

​

(45)

​

​

(362)

​

​

(407)

Convertible notes payable, net

​

​

2,801

​

​

26,117

​

​

28,918

​

​

2,786

​

​

27,007

​

​

29,793

Accrued interest on convertible notes

​

​

4,828

​

​

11,564

​

​

16,392

​

​

4,634

​

​

10,593

​

​

15,227

Outstanding convertible notes payable, net and accrued interest

​

$

7,629

​

$

37,681

​

$

45,310

​

$

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	​	​	15	​	​	110	​	​	125
Interest expense	​	​	194	​	​	971	​	​	1,165
Fair market value of shares and warrants exchanged for repayment	​	​	-	​	​	(1,180)	​	​	(1,180)
Difference between market value of common shares and reduction of principal	​	​	-	​	​	180	​	​	180
Outstanding balance at August 31, 2024	​	$	7,629	​	$	37,681	​	$	45,310

​

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April 2, 2021 & April 23, 2021 Notes

Key terms of the outstanding convertible notes are as follows:

​

​	​	​	​	​	​	​	​	​
​	​	August 31, 2024
​		April 2, 2021 Note		​	April 23, 2021 Note	​
Interest rate per annum	​	​	10	%	​	​	10	%
Conversion price per share upon fivetrading days' notice	​	$	10.00	​	​	$	10.00	​
Party that controls the conversion rights	​	​	Investor	​	​	​	Investor	​
Maturity date	​	​	April 5, 2025	​	​	​	April 23, 2025	​
Security interest	​	​	All Company assets excluding intellectual property	​

​

In addition to standard anti-dilution adjustments, the conversion price of the April 2, 2021 Note and April 23, 2021 Note is subject to full-ratchet anti-dilution protection, pursuant to which the conversion price will be automatically reduced to equal the effective price per share in any new offering by the Company of equity securities that have registration rights, are registered, or become registered under the Securities Act of 1933, as amended (the "Securities Act"). The April 2, 2021 Note and April 23, 2021 Note provide for liquidated damages upon failure to deliver common stock within specified timeframes and require the Company to maintain a share reservation of 6.0 millionshares of common stock for each Note.

During the three months ended August 31, 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 $1.0 million, which was exchanged concurrently with the issuance of approximately 8.8 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 $26.4 million. The Company accounted for the Partitioned Notes and the exchange settlements as induced conversions, and, accordingly, recorded a non-cash loss on convertible debt induced conversion of $1.2 million for the three months ended August 31, 2024.

As of September 30, 2024, the holders of the April 2, 2021 and April 23, 2021 Notes waived all provisions in the convertible notes that, based on the occurrence of various events through that date, could have triggered the imposition of a default interest rate, a downward adjustment of the conversion price, or specified other provisions relating to default, breach or imposition of a penalty. Accordingly, the Company was not in default under the Notes on September 30, 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-monthterm to accredited investors through a placement agent ("Placement Agent Notes") for a total principal amount of approximately $2.3million. The Placement Agent Notes were secured by the net cash recovery, if any, by the Company in its dispute with Amarex and provided the investors with a right to convert the unpaid principal and accrued but unpaid interest into shares of common stock upon the occurrence of an event of default.The Placement Agent Notes had maturity dates during the fiscal year ending May 31, 2025.

In connection with the note issuances, the Company issued warrants to investors to purchase approximately 1.3million shares of common stock with a three-yearterm and an exercise price of $0.50per share. The Company also issued warrants to purchase approximately 0.4million shares of common stock to the placement agent with a ten-yearterm and an exercise price of $0.26per share.

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

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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 three months ended August 31, 2024. In accordance with the prescribed accounting guidance, the Company measured 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.

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 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		(2,110)	​	$	0.43		​	​		​
Warrants outstanding at August 31, 2024		232,248	​	$	0.26		4.28	​	$	5,045
Warrants outstanding and exercisable at August 31, 2024		232,248	​	$	0.26		4.28	​	$	5,045

​

​

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Note 6. Equity Incentive Plan

Equity Incentive Plan ("EIP")

​

As of August 31, 2024, the Company had one active equity incentive plan, the CytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan (the "EIP"). As of August 31, 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 service in exchange for the award and, as forfeitures occur, the associated compensation cost recognized to date is reversed. For awards with performance-based payout conditions, the Company recognizes compensation cost based on the probability of achieving the performance conditions, with changes in expectations recognized as an adjustment to earnings in the period of change. Any recognized compensation cost is reversed if the conditions ultimately are not met.

Stock-based compensation for the three months ended August 31, 2024 and 2023 was $0.2 million and $0.5 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		-	​	$	-		​	​		​
Exercised		-	​	$	-		​	​		​
Forfeited, expired, and cancelled		(50)	​	$	0.66		​	​		​
Options outstanding at August 31, 2024		25,799	​	$	0.60		7.54	​	$	-
Options outstanding and exercisable at August 31, 2024		20,148	​	$	0.70		7.07	​	$	-

​

​

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Note 7. Income (Loss) per Share

Basic income (loss) per share is computed by dividing the net income (loss) adjusted for preferred stock dividends by the weighted average number of common shares outstanding during the period. Diluted income (loss) per share includes the weighted average common shares outstanding and potentially dilutive common stock equivalents. The reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share computations are as follows:

​

​	​	​	​	​	​
​	Three months ended August 31,
(in thousands, except per share amounts)	2024	​	2023
Basic net income (loss) per share:	​	​	​	​	​
Net income (loss)	$	19,227	​	$	(11,571)
Less: Accrued preferred stock dividends	​	(372)	​	​	(373)
Net income (loss) applicable to common stockholders	$	18,855	​	$	(11,944)
Basic:	​	​	​	​	​
Weighted average common shares outstanding	​	1,135,043	​	​	923,587
Income (loss) per share	$	0.02	​	$	(0.01)
Diluted net income (loss) per share:	​	​	​	​	​
Net income (loss)	$	18,855	​	$	(11,944)
Reallocation of undistributed earnings as a result of conversion of preferred stock	​	372	​	​	-
Net income (loss) applicable to common stockholders	$	19,227	​	$	(11,944)
​	​	​	​	​	​
Number of shares used in basic computation	​	1,135,043	​	​	923,587
Weighted-average effect of dilutive securities	​	​	​	​	​
Warrant exercises	​	25,450	​	​	-
Preferred stock conversions	​	37,794	​	​	-
Diluted weighted average common shares outstanding	​	1,198,287	​	​	923,587
Diluted income (loss) per share	$	0.02	​	$	(0.01)

​

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 months ended August 31,	​
(in thousands)	2024		2023	​
Stock options and warrants	232,597	​	276,503	​
Convertible notes	12,000	​	12,000	​
Convertible preferred stock	-	​	34,818	​
Reserved for issuance of common stock through a placement agent	-	​	14,663	​
Reserved for issuance of common stock related to note conversion	-	​	11,474	​

​

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 noincome tax expense for the three months ended August 31, 2024 and 2023. The provision for income taxes for the three months ended August 31, 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 months ended August 31, 2024, the Company's recognized effective tax rate differs from the U.S. federal statutory rate due to the Company

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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 due on or 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 due on or 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 August 31, 2024 and 2023 were approximately $32.0thousand and $42.6thousand, respectively. Operating lease right-of-use assets are included in other non-current assets and the current portion of operating lease liabilities are included in accrued liabilities and compensation on the consolidated balance sheets. The long-term operating lease liabilities are presented separately as operating lease on the consolidated balance sheets. The following table summarizes the operating lease balances:

​

​	​	​	​	​	​	​	​
​	​	​	​
(in thousands)	​	​	August 31, 2024	​	​	May 31, 2024	​
Assets	​	​	​	​	​	​	​
Right-of-use asset	​	$	230	​	$	264	​
Liabilities	​	​	​	​	​	​	​
Current operating lease liability	​	$	142	​	$	142	​
Non-current operating lease liability	​		105	​		141	​
Total operating lease liability	​	$	247	​	$	283	​

​

​

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The minimum (base rental) lease payments are expected to be as follows as of August 31, 2024 (in thousands):

​

​	​	​	​
Fiscal Year	​	Amount
2025 - 9 months remaining	​	$	139
2026	​	​	169
Thereafter	​	​	-
Total operating lease payments	​	​	308
Less: imputed interest	​	​	(61)
Present value of operating lease liabilities	​	$	247

​

Supplemental information related to operating leases was as follows:

​

​	​	​	​
​	​	August 31, 2024
Weighted average remaining lease term	​	1.7	years
Weighted average discount rate	​	10.0	%

​

Distribution and licensing commitments

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

Legal proceedings

As of August 31, 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.

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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. The Company cannot predict the ultimate outcome of the DOJ or SEC investigations or the cases against Mr. Pourhassan, nor can it predict whether any other governmental authorities will initiate separate investigations or litigation. The investigations and any related legal and administrative proceedings could include a wide variety of outcomes, including the institution of administrative, civil injunctive or criminal proceedings involving the Company and/or former executives and/or former directors in addition to Mr. Pourhassan, the imposition of fines and other penalties, remedies and/or sanctions, modifications to business practices and compliance programs and/or referral

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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.

Note 10. Subsequent Events

The Company's management has evaluated subsequent events through the date of issuance of the consolidated financial statements included herein. There have been no subsequent events that occurred during such period that would require disclosure in this Form 10-Q or would be required to be recognized in the consolidated financial statements as of and for the three months ended August 31, 2024.

​

​

18

Table of Contents

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

​

Certain information included in this quarterly report on Form 10Q 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 in Part II, Item 1A and 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 commercials 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.

19

Table of Contents

Overview

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, including HIV and MASH.

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

1.	Conducting a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer;

2.	Conducting a Phase II study exploring leronlimab and its effects on inflammation; and

3.	Continuing our work researching and developing a new or modified long-acting version of leronlimab.

Other programs that may be pursued include steatosis and liver fibrosis associated with MASH, either alone or as a combination therapy; and for metastatic triple-negative breast cancer with current standard of care, and/or exploring other trials with current standard of care and other cancer and immunologic indications.

We will need significant additional funding to execute the business strategy described above, including conducting 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.

Corporate developments

During the quarter ended August 31, 2024, the Company completed a tender offer resulting in net proceeds of approximately $10.4 million.

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, against the Company's outstanding balance, reducing the 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.

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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 Part II, Item 1A Risk Factors included in this quarterly report and Item 1A. Risk Factors in our 2024 Form 10-K.

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

​

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three months ended August 31,

​

Change

​

(in thousands, except for per share data)

2024

2023

$

%

​

Operating expenses:

​

​

​

​

​

​

​

​

​

​

General and administrative

​

$

1,604

$

2,688

​

$

(1,084)

​

(40)

%

Research and development

​

(24,046)

1,914

​

(25,960)

​

(1,356)

​

Depreciation

​

5

10

​

(5)

​

(50)

​

Total operating expenses

​

(22,437)

4,612

​

(27,049)

​

(586)

​

Operating gain (loss)

​

22,437

(4,612)

​

27,049

​

586

​

Interest and other income (expense):

​

​

​

​

​

​

​

​

​

​

​

​

Interest income

​

​

126

​

​

-

​

​

126

​

100

​

Interest on convertible notes

​

​

(1,165)

​

​

(1,197)

​

​

32

​

3

​

Amortization of discount on convertible notes

​

(125)

(400)

​

275

​

69

​

Amortization of debt issuance costs

​

​

-

​

​

(366)

​

​

366

​

100

​

Loss on induced conversion

​

​

(1,180)

​

​

(2,004)

​

​

824

​

41

​

Finance charges

​

(14)

(912)

​

898

​

98

​

Loss on note extinguishment

​

-

(2,084)

​

2,084

​

100

​

(Loss) gain on derivatives

​

​

(852)

​

​

4

​

​

(856)

​

(21,400)

​

Total interest and other expenses

​

(3,210)

(6,959)

​

3,749

​

54

​

Gain (loss) before income taxes

​

19,227

(11,571)

​

30,798

​

266

​

Income tax benefit

​

-

-

​

-

​

-

​

Net income (loss)

​

$

19,227

​

$

(11,571)

​

$

30,798

​

266

%

Income (Loss) per share:

​

​

​

​

​

​

​

​

​

​

​

Basic

​

$

0.02

​

$

(0.01)

​

$

0.03

​

300

​

Diluted

​

$

0.02

$

(0.01)

​

$

0.03

​

300

%

​

​

​

​

​

​

​

​

​

​

​

​

​

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

​

​

​

​

​

​

​

​

​

​

​

​

Basic

​

​

1,135,043

​

​

923,587

​

​

211,456

​

23

​

Diluted

​

​

1,198,287

​

​

923,587

​

​

274,700

​

30

%

​