CytoDyn Inc.
For the period ended Feb 28, 2025. Filed Apr 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Feb 28, 2025 · Filed Apr 14, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS
Consolidated Balance Sheets
(Unaudited, in thousands, except par value)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · · February 28, 2025 · · May 31, 2024 | ||||||
| Assets · · · · · | ||||||
| Current assets: · · · | ||||||
| Cash and cash equivalents | | $16,400 | | $3,110 | ||
| Restricted cash | | — | | 6,704 | ||
| Prepaid expenses | | 513 | | 463 | ||
| Prepaid service fees | | 2,071 | | 538 | ||
| Other receivables (Note 9) | | | 2,000 | | | — |
| Total current assets | | 20,984 | | 10,815 | ||
| Other non-current assets | | 207 | | 321 | ||
| Total assets | | $21,191 | | $11,136 | ||
| Liabilities and Stockholders’ Deficit | | | ||||
| Current liabilities: | | | ||||
| Accounts payable | | $15,127 | | $29,561 | ||
| Accrued liabilities and compensation | | 1,704 | | 2,810 | ||
| Accrued interest on convertible notes | | 18,696 | | 15,227 | ||
| Accrued dividends on convertible preferred stock | | 7,897 | | 6,791 | ||
| Convertible notes payable, net | | 27,141 | | 29,793 | ||
| Total current liabilities | | 70,565 | | 84,182 | ||
| Operating leases | | 34 | | 141 | ||
| Other liabilities (Note 9) | | | 43,571 | | | 43,571 |
| Total liabilities | | 114,170 | | 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 February 28, 2025 and May 31, 2024 | | — | | — | ||
| Series C convertible preferred stock, $0.001 par value; 8 authorized; 6 issued and outstanding at February 28, 2025 and May 31, 2024 | | — | | — | ||
| Series D convertible preferred stock, $0.001 par value; 12 authorized; 9 issued and outstanding at February 28, 2025 and May 31, 2024 | | — | | — | ||
| Common stock, $0.001 par value; 1,750,000 shares authorized; 1,232,591 and 1,059,002 issued, and 1,232,305 and 1,058,559 outstanding at February 28, 2025 and May 31, 2024, respectively | | 1,233 | | 1,059 | ||
| Treasury stock, $0.001 par value; 286 and 443 shares at February 28, 2025 and May 31, 2024, respectively | | | — | | | — |
| Additional paid-in capital | | 787,618 | | 773,714 | ||
| Accumulated deficit | | (881,830) | | (891,531) | ||
| Total stockholders’ deficit | | (92,979) | | (116,758) | ||
| Total liabilities and stockholders' deficit | | $21,191 | | $11,136 | ||
Consolidated Statements of Operations
(Unaudited, in thousands, except per share data)
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended · · Nine months ended | ||||||||||||
| · February 28, 2025 · February 29, 2024 · February 28, 2025 · February 29, 2024 | ||||||||||||
| Operating expenses: · · · · | ||||||||||||
| General and administrative | | $1,511 | | $2,757 | | $5,409 | | $7,756 | ||||
| Research and development | | 2,487 | | 650 | | (20,150) | | 3,643 | ||||
| Depreciation | | 5 | | 7 | | 14 | | 25 | ||||
| Total operating expenses | | 4,003 | | 3,414 | | (14,727) | | 11,424 | ||||
| Operating (loss) gain | | (4,003) | | (3,414) | | 14,727 | | (11,424) | ||||
| Interest and other income (expense): | | | | | | | | | | | | |
| Interest income | | | 173 | | | — | | | 441 | | | — |
| Interest on convertible notes | | (1,143) | | (1,151) | | (3,469) | | (3,512) | ||||
| Amortization of discount on convertible notes | | | (110) | | | (409) | | | (348) | | | (951) |
| Amortization of debt issuance costs | | — | | (203) | | — | | (572) | ||||
| Issuance costs for private placement of shares and warrants through placement agent | | | — | | | — | | | — | | | (906) |
| Loss on induced conversion | | — | | | (3,353) | | | (1,180) | | | (5,993) | |
| Finance charges | | (2) | | (882) | | (25) | | (2,685) | ||||
| Loss on note extinguishment | | — | | (1,550) | | — | | (6,040) | ||||
| Gain on restructuring of payables | | 327 | | — | | 407 | | — | ||||
| Loss on derivatives | | | — | | | (958) | | | (852) | | | (971) |
| Total interest and other expenses | | (755) | | (8,506) | | (5,026) | | (21,630) | ||||
| (Loss) gain before income taxes | | (4,758) | | (11,920) | | 9,701 | | (33,054) | ||||
| Income tax benefit | | — | | — | | — | | — | ||||
| Net (loss) income | | $(4,758) | | $(11,920) | | $9,701 | | $(33,054) | ||||
| | | | | | | | | | | | | |
| (Loss) income per share: | | | | | | | | | | | | |
| Basic | | $(0.00) | | $(0.01) | | $0.01 | | $(0.04) | ||||
| Diluted | | $(0.00) | | $(0.01) | | $0.01 | | $(0.04) | ||||
| | | | | | | | | | | | | |
| Weighted average common shares used in calculation of (loss) income per share: | | | | | | | | | | | | |
| Basic | | | 1,228,259 | | | 982,209 | | | 1,194,561 | | | 954,814 |
| Diluted | | | 1,228,259 | | | 982,209 | | | 1,225,538 | | | 954,814 |
Consolidated Statement of Changes in Stockholders’ Deficit
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · 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) |
| Issuance of stock for convertible note repayment | | — | | | — | | 7,802 | | | 8 | | — | | | — | | | 1,165 | | | — | | | 1,173 |
| Stock option exercises | | — | | | — | | 100 | | | — | | — | | | — | | | 21 | | | — | | | 21 |
| Stock issued for compensation | | — | | | — | | 162 | | | — | | — | | | — | | | 40 | | | — | | 40 | |
| Stock adjustment | | — | | | — | | (651) | | | (1) | | (157) | | | — | | | — | | | — | | (1) | |
| Exercise of warrants, net of offering costs | | — | | | — | | 1,661 | | | 2 | | — | | | — | | | (1) | | | — | | 1 | |
| Dividends accrued on Series C and D preferred stock | | — | | | — | | — | | | — | | — | | | — | | | (365) | | | — | | (365) | |
| Stock-based compensation | | — | | | — | | — | | | — | | — | | | — | | | 300 | | | — | | 300 | |
| Net loss | | — | | | — | | — | | | — | | — | | | — | | | — | | | (4,758) | | (4,758) | |
| Balance at February 28, 2025 | | 34 | | $— | | 1,232,591 | | $1,233 | | 286 | | $— | | $787,618 | | $(881,830) | | $(92,979) | ||||||
Consolidated Statement of Changes in Stockholders’ Deficit
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · 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) |
| Issuance of stock for convertible note repayment | | — | | | — | | 18,674 | | 19 | | — | | — | | | 2,731 | | — | | 2,750 | ||||
| Loss on induced conversion | | — | | | — | | — | | | — | | — | | | — | | | 3,353 | | | — | | | 3,353 |
| Warrants issued in note offering | | — | | | — | | — | | | — | | — | | | — | | | 179 | | | — | | | 179 |
| Discount related to private offering modification | | — | | | — | | — | | | — | | — | | | — | | | 137 | | | — | | | 137 |
| Stock issued for compensation | | — | | | — | | 408 | | | — | | — | | | — | | | 75 | | | — | | | 75 |
| Dividends accrued on Series C and D convertible preferred stock | | — | | | — | | — | | | — | | — | | | — | | | (369) | | | — | | | (369) |
| Stock-based compensation | | — | | — | | — | | — | | — | | — | | 794 | | — | | 794 | ||||||
| Net loss | | — | | — | | — | | — | | — | | — | | — | | (11,920) | | (11,920) | ||||||
| Balance at February 29, 2024 | | 34 | | $— | | 990,368 | | $990 | | 443 | | $— | | $754,372 | | $(874,744) | | $(119,382) | ||||||
Consolidated Statements of Cash Flows
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Nine months ended | ||||||
| | February 28, 2025 | February 29, 2024 | ||||
| | | | | | | |
| Cash flows from operating activities: · · · | ||||||
| Net income (loss) | | $9,701 | | $(33,054) | ||
| Adjustments to reconcile net income (loss) to net cash used in operating activities: | | | ||||
| Depreciation | | 14 | | 25 | ||
| Amortization of debt issuance costs | | — | | 572 | ||
| Issuance costs for private placement of shares and warrants through placement agent | | | — | | | 906 |
| Amortization of discount on convertible notes | | 348 | | 951 | ||
| Gain on restructuring of payables | | | (407) | | | — |
| Loss on derivatives | | | 852 | | | 971 |
| Loss on induced conversion | | | 1,180 | | | 5,993 |
| Loss on note extinguishment | | — | | 6,040 | ||
| Stock-based compensation | | 1,013 | | 1,944 | ||
| Changes in operating assets and liabilities: | | | | |||
| Prepaid expenses and other assets | | | (3,483) | | | (28) |
| Accounts payable, accrued expenses, and other liabilities | | (12,320) | | 6,348 | ||
| Net cash used in operating activities | | (3,102) | | (9,332) | ||
| 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 | | — | | 5,696 | ||
| Proceeds from warrant exercises | | — | | 300 | ||
| Proceeds from convertible note and warrant issuances, net of offering costs | | — | | 2,011 | ||
| Proceeds from exercise of stock options | | 21 | | — | ||
| Proceeds held in trust | | — | | 300 | ||
| Cash paid for note payable | | | (710) | | | — |
| Net cash provided by financing activities | | 9,688 | | 8,307 | ||
| Net change in cash and restricted cash | | 6,586 | | (1,025) | ||
| Cash, cash equivalents, and restricted cash at beginning of period | | 9,814 | | 9,048 | ||
| Cash, cash equivalents, and restricted cash at end of period | | $16,400 | | $8,023 | ||
| Cash, cash equivalents, and restricted cash consisted of the following: | | | | | | |
| Cash and cash equivalents | | $16,400 | | $1,404 | ||
| Restricted cash | | | — | | | 6,619 |
| Total cash, cash equivalents, and restricted cash | | $16,400 | | $8,023 | ||
| Supplemental disclosure: | | | | | | |
| Cash paid for interest | | $25 | | $44 | ||
| Non-cash investing and financing transactions: | | | ||||
| Derivative liability associated with warrants | | $— | | $102 | ||
| Issuance of common stock for principal of convertible notes | | $2,593 | | $4,750 | ||
| Accrued dividends on Series C and D convertible preferred stock | | $1,106 | | $1,110 | ||
| Warrants issued to placement agent | | $— | | $413 | ||
| Note conversion to common stock and warrants | | $— | | $3,302 | ||
CYTODYN INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
AS OF FEBRUARY 28, 2025
(Unaudited)
Note 1. Organization
CytoDyn Inc. (together with its wholly owned subsidiary, 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 investigates leronlimab as a viral entry inhibitor believed to competitively bind to the N-terminus and second extracellular loop of the CCR5 receptor. The CCR5 receptor is believed to be implicated in immune-mediated illnesses. Leronlimab is being studied in solid tumors in oncology. The Company also strategically works with select partners to explore leronlimab’s potential benefits in certain inflammatory diseases.
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 nine months ended February 28, 2025. The Company has an accumulated deficit of approximately $881.8 million as of February 28, 2025. 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 February 28, 2025, was approximately $16.2 million. The Company did not have a money market fund balance as of May 31, 2024.
Restricted cash
As of February 28, 2025, the Company hadno 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 the 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 chief operating decision maker (“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 will 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. In January 2025, the FASB issued ASU 2025-01, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) – Clarifying the Effective Date” to clarify the effective date for non-calendar year-end entities. The amendments in this ASU will be effective for annual periods beginning after December 15, 2026, and interim reporting periods within annual 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.
Note 3. Accrued Liabilities and Compensation
The components of accrued liabilities and compensation are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| (in thousands) | | | February 28, 2025 | | | May 31, 2024 |
| Compensation and related expense | | $224 | | $208 | ||
| Legal fees and settlement | | | — | | | 7 |
| Clinical expense | | | 357 | | | 329 |
| License fees | | | 780 | | | 1,799 |
| Lease payable | | | 142 | | | 142 |
| Investor proceeds held in escrow | | | — | | | 300 |
| Other liabilities | | | 201 | | | 25 |
| Total accrued liabilities | | $1,704 | | $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.* *
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · February 28, 2025 · · 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 | | $23 | | $— | | $— | | $19 | | $— | | $— | ||||||
| Accrued dividends | | $— | | $3,610 | | $4,287 | | $— | | $3,135 | | $3,656 | ||||||
| Total shares of common stock if dividends converted | | | 46 | | | 7,220 | | | 8,574 | | | 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 February 28, 2025 and May 31, 2024:
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · February 28, 2025 · · 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 | | $24,369 | | $27,200 | | $2,831 | | $27,369 | | $30,200 | ||||||
| Less: Unamortized debt discount and issuance costs | | | (5) | | | (54) | | | (59) | | | (45) | | | (362) | | | (407) |
| Convertible notes payable, net | | | 2,826 | | | 24,315 | | | 27,141 | | | 2,786 | | | 27,007 | | | 29,793 |
| Accrued interest on convertible notes | | | 5,223 | | | 13,473 | | | 18,696 | | | 4,634 | | | 10,593 | | | 15,227 |
| Outstanding convertible notes payable, net and accrued interest | | $8,049 | | $37,788 | | $45,837 | | $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 | |||
| Amortization of issuance discount and costs | | | 40 | | | 308 | | | 348 |
| Interest expense | | | 589 | | | 2,880 | | | 3,469 |
| Fair market value of shares and warrants exchanged for repayment | | | — | | | (2,773) | | | (2,773) |
| Difference between market value ofcommon shares and reduction of principal | | | — | | | (227) | | | (227) |
| Outstanding balance at February 28, 2025 | | $8,049 | | $37,788 | | $45,837 | |||
April 2, 2021 & April 23, 2021 Notes
Key terms of the outstanding convertible notes (the “Notes”) are as follows:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · February 28, 2025 | ||||||||
| · 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. Subsequent to February 28, 2025, the Company and the noteholders entered into amendments to the existing Notes, extending the maturity date of each Note by 12 months and lowering the interest rate of the Notes to 6%. For further information, see Note 10,Subsequent Events.
During the nine months ended February 28, 2025, 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 $3.0 million, which was exchanged concurrently with the issuance of approximately 19.8 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 $24.4 million. The Company accounted for the Partitioned Notes and the exchange settlements where the shares exchanged were worth more 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 nine months ended February 28, 2025. The Company recognized an approximate $0.4 million gain on restructuring of payables during the nine months ended February 28, 2025 for the Partitioned Notes and the exchange settlement where the shares exchanged were worth less than principal extinguished.
As of the filing date of this report, 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 the filing date of this report.
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 ofone share plusone warrant was fixed at 90% of the lower of the intraday volume weighted average price (“VWAP”) on the date of the first closing and last closing of the private placement, while the exercise price of the warrants was set at $0.306 per share, compared to $0.50 per share in the original private placement. 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 agentin 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 nine months ended February 28, 2025. In accordance with the prescribed accounting guidance, the Company measured the fair value of the derivative liability 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 an exercise price of $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 exercise price 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 | (129,466) | | $0.09 | | | $6,386 |
| Forfeited, expired, and cancelled | (7,974) | | $0.55 | | | |
| Warrants outstanding at February 28, 2025 | 224,005 | | $0.25 | 3.87 | | $24,170 |
| Warrants outstanding and exercisable at February 28, 2025 | 224,005 | | $0.25 | 3.87 | | $24,170 |
Warrant exercises
During the nine months ended February 28, 2025, the Company issued approximately 1.7 million shares of common stock in connection with the cashless exercise of approximately 2.4 million warrants with stated exercise prices of $0.09387 per share.
War
Note 6. Equity Incentive Plan
Equity Incentive Plan
As of February 28, 2025, the Company hadone active equity incentive plan, theCytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan (the “EIP”). As of February 28, 2025 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 February 28, 2025 and February 29, 2024 was $0.3 million and $0.9 million, respectively, and for the nine months ended February 28, 2025 and February 29, 2024 was $1.0 million and $1.9 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 exercise price 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 | (100) | | $0.21 | | | 10 |
| Forfeited, expired, and cancelled | (50) | | $0.66 | | | |
| Options outstanding at February 28, 2025 | 37,374 | | $0.46 | 7.86 | | $3,325 |
| Options outstanding and exercisable at February 28, 2025 | 26,598 | | $0.57 | 7.29 | | $1,842 |
During the nine months ended February 28, 2025 and February 29, 2024, stock options for approximately 11.7 million shares and 11.3 million shares, respectively, were granted. Of the current year options, approximately 5.7 million vest over four years, and approximately 6.0 million vest overone year. Of the prior year options, approximately 0.5 million options vest when performance conditions are completed, approximately 2.7 million vest over four years, approximately 4.0 million vest overone year, and approximately 4.1 million were cancelled and new options were granted with the same vesting schedule and expiration dates as the original cancelled options. 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 $0.17 for the stock options granted in the nine months ended February 28, 2025 and February 29, 2024, respectively.
Issuance of shares to consultants
The Board has approved the issuance under the EIP of shares of common stock to consultants as payment for services provided. During the nine months ended February 28, 2025 and February 29, 2024, a total of 161,538 and 1,499,951 shares of common stock, respectively, were issued pursuant to the respective award agreements with the consultants.
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 nine months ended February 28, 2025 and February 29, 2024 were calculated as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended · · Nine months ended | ||||||||||||
| (in thousands, except per share amounts) · · February 28, 2025 · February 29, 2024 · · February 28, 2025 · · February 29, 2024 | ||||||||||||
| Numerator: | | | | | | | | | | | | |
| Net (loss) income | | $(4,758) | | $(11,920) | | $9,701 | | $(33,054) | ||||
| Less: Accrued preferred stock dividends | | | (365) | | | (369) | | | (1,106) | | | (1,110) |
| Net (loss) income applicable to common stockholders | | $(5,123) | | $(12,289) | | $8,595 | | $(34,164) | ||||
| Denominator: | | | | | | | | | | | | |
| Basic weighted average common shares outstanding | | | 1,228,259 | | | 982,209 | | | 1,194,561 | | | 954,814 |
| Effect of dilutive securities: | | | | | | | | | | | | |
| Warrant exercises | | | — | | | — | | | 30,352 | | | — |
| Option exercises | | | — | | | — | | | 625 | | | — |
| Diluted weighted average common shares outstanding | | | 1,228,259 | | | 982,209 | | | 1,225,538 | | | 954,814 |
| | | | | | | | | | | | | |
| Basic (loss) income per share | | $(0.00) | | $(0.01) | | $0.01 | | $(0.04) | ||||
| Diluted (loss) income per share | | $(0.00) | | $(0.01) | | $0.01 | | $(0.04) | ||||
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 nine months ended · | ||||
| (in thousands) · February 28, 2025 · February 29, 2024 · | ||||
| Stock options, and warrants | 231,027 | | 315,808 | |
| Convertible notes | 12,000 | | 12,000 | |
| Convertible preferred stock | 39,265 | | 36,298 | |
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 hadno income tax expense for the three and nine months ended February 28, 2025 and February 29, 2024. The provision for income taxes for the three and nine months ended February 28, 2025 and February 29, 2024 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 nine months ended February 28, 2025, 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) 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 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 February 28, 2025 and February 29, 2024 were approximately$26.0 thousand and$32.0 thousand, respectively and for the nine months ended February 28, 2025 and February 29, 2024 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) | | | February 28, 2025 | | | May 31, 2024 | |
| Assets | | | | | | | |
| Right-of-use asset | | $163 | | $264 | | ||
| Liabilities | | | | | | | |
| Current operating lease liability | | $142 | | $142 | | ||
| Non-current operating lease liability | | 34 | | 141 | | ||
| Total operating lease liability | | $176 | | $283 | | ||
The minimum (base rental) lease payments are expected to be as follows as of February 28, 2025 (in thousands):
| | | | |
|---|---|---|---|
| Fiscal Year · · Amount | |||
| 2025 - 3 months remaining | | $46 | |
| 2026 | | | 169 |
| Thereafter | | | — |
| Total operating lease payments | | | 215 |
| Less: imputed interest | | | (39) |
| Present value of operating lease liabilities | | $176 | |
Supplemental information related to operating leases was as follows:
| | | | |
|---|---|---|---|
| · · February 28, 2025 | |||
| Weighted average remaining lease term | | 1.2 | 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 Clinical Research Organization (“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 February 28, 2025, 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 human immunodeficiency virus (“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 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 currently scheduled to be sentenced in May 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.
Investor Lawsuit Seeking Issuance of Additional Shares
In January 2025, two former investors and current shareholders, filed an action against the Company in relation to a dispute over how many shares were issued to them following their direct investment(s) with the Company. The former investors claim that the final pricing utilized to calculate the issuance of shares to them in 2022 was incorrect, and that they are entitled to more shares than were issued. The complaint presents legal claims sounding in breach of fiduciary duty, misrepresentation, fraud, negligence, theft, and breach of contract.
The Company's position is that the claims are without any factual support, or support under applicable law and/or the underlying investment documents. The Company views this action as an attempt to extract more shares without further/fair investment and plans to vigorously defend itself.
Note 10. Subsequent Events
Extension(s) to April 2, 2021 and April 23, 2021 Notes
In April 2025, the Company and the holders of convertible notes issued by the Company on April 2, 2021 and April 23, 2021 (the “Noteholders”) agreed to extend the maturity date of each of the notes byone year (the ”Extension Period”). The Company agreed to a total monthly payment of $750,000 covering both notes until the extended maturity date. During the Extension Period, the Company will issue shares of common stock equal in value to the $750,000 monthly payment calculated based on the lower of (i) the previous trading day’s closing price, or (ii) the average of thefive previous trading day closing prices. The interest rate for each note was also lowered to 6% as part of the extension.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.