CytoDyn Inc
For the period ended May 31, 2024. Filed Aug 15, 2024.
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FY2024 · Filed Aug 15, 2024
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
AS OF MAY 31, 2024
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 CCR5 receptor.
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 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 MASH. Leronlimab is being or has been studied in MASH, solid tumors in oncology, COVID-19, Long-COVID, and other HIV indications where CCR5 is believed to play an integral role in the pathogenesis of disease.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of CytoDyn Inc. and its wholly owned subsidiary, CytoDyn Operations Inc. Intercompany transactions and balances are eliminated in consolidation.
Going Concern
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates realization of assets and satisfaction of liabilities in the normal course of business. As presented in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of $49.8 million and $79.8 million for the fiscal years ended May 31, 2024, and 2023, respectively, and has an accumulated deficit of approximately $891.5 million as of May 31, 2024. These factors, among others, including the various matters discussed in Note 10,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 preparation of the consolidated financial statements in accordance with accounting principles generally accepted in the United States (“U.S. GAAP” or “GAAP”) requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. Estimates are assessed each period and updated to reflect current information, such as the status of our analysis of the
results of our clinical trials and/or discussions with the FDA, which could have an impact on the Company’s significant accounting estimates and assumptions. The Company’s estimates are based on historical experience and on various 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 Restricted Cash
Cash is maintained at federally insured financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to cash balances. Balances in excess of federally insured limits were approximately $2.9 million of the cash balance and approximately $6.7 million of the restricted cash balance at May 31, 2024. Balances in excess of federally insured limits were approximately $2.3 million of the cash balance and approximately $5.5 million of the restricted cash balance at May 31, 2023.
As of May 31, 2024, the Company recorded approximately $6.7 million of restricted cash. The restricted cash balance is related to cash held as collateral in connection with a surety bond that was posted as required in the litigation with Amarex Clinical Research, LLC (“Amarex”) and will remain as restricted cash until the litigation is resolved. On July 2, 2024, the legal matter was resolved and the surety bond was released to the Company, in full, as part of the settlement agreement.
Inventories
Capitalized Pre-launch Inventories
Pre-launch inventories comprised raw materials required to commercially produce leronlimab and substantially completed commercially produced leronlimab in anticipation of commercial sales of the product upon potential regulatory approval as a combination therapy for HIV patients in the United States, and potential emergency use authorizations for COVID-19. The Company’s pre-launch inventories consisted of (1) raw materials purchased for commercial production, (2) work-in-progress materials which consist of bulk drug substance, which is the manufactured drug stored in bulk storage, and (3) drug product, which is the manufactured drug in unlabeled vials. The consumption of raw materials during production is classified as work-in-progress until saleable. Once it is determined to be in saleable condition, following regulatory approval, inventory is classified as finished goods. Inventories, net of write-offs had azero balance for the fiscal years ended May 31, 2024 and 2023.
The Company capitalizes inventories procured or produced in preparation for product launches. Typically, capitalization of such inventory begins when the results of clinical trials have reached a status sufficient to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced, and the Company has determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The material factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and status of the Company’s regulatory applications. The Company closely monitors the status of the product within the regulatory review and approval process, including all relevant communications with regulatory authorities. If the Company becomes aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing, or labeling, it may make a determination that the related inventory no longer qualifies for capitalization.
The Company determines whether raw materials purchased for commercial production are usable for production based on the manufacturer’s assigned expiration date. In evaluating whether raw materials included in the pre-launch inventories will be usable for production, the Company takes into account the shelf-life of raw materials at the time they are expected to be used in manufacturing. Any raw materials past expiration date at the time of the next manufacturing run are removed from inventory.
As one stage of the manufacturing process, the Company produces work-in-progress materials which consist of bulk drug substance, which is the manufactured drug stored in bulk storage. The initial shelf-life of bulk drug substance is established based on periodically performed stability studies and is set atfour years from the date of manufacturing. Bulk drug substance is subject to deep freeze stability studies performed on a periodic basis in accordance with the established stability protocols. If drug substance meets suitability criteria beyond the initial shelf-life, its shelf-life is
extended by another four years. Regardless of the number of stability studies performed, if drug substance continues to meet prespecified suitability parameters it may be used in manufacturing; if drug substance fails to meet suitability criteria beyond its assigned shelf-life at that time, it may no longer be used and is considered to be expired.
The Company utilizes resins, a reusable raw material, in its bulk drug manufacturing process. Shelf-life of a resin used in commercial manufacturing of biologics is determined by the number of cycles for which it has been validated to be used in a manufacturing process before it is considered unusable. Unpacked and unused resins have a manufacturer’s expiration date by which resins are expected to start being used in the manufacturing process without loss of their properties. Prior to a new manufacturing campaign, and between manufacturing campaigns, the resins are removed from storage and are treated and tested for suitability. Once resins are used in the manufacturing process, their shelf-life is measured by a validated predetermined number of manufacturing cycles they are usable for, conditional on appropriate storage solution under controlled environment between production campaigns, as well as by performing pre-production usability testing. Before a manufacturing campaign, each resin is tested for suitability. Regardless of the number of cycles, if a resin fails to meet prespecified suitability parameters it may not be used in manufacturing; likewise, even if the resin meets suitability criteria beyond the lifetime cycles, it may no longer be used. The cost of the resins used in a manufacturing campaign is allocated to the cost of the drug product in vials.
The Company values its inventory at the lower of cost or net realizable value using the average cost method. Inventory is evaluated for recoverability by considering the likelihood that revenue will be obtained from the future sale of the related inventory considering the status of the product within the regulatory approval process. The Company evaluates its inventory levels on a quarterly basis and writes down inventory that became obsolete, has a cost in excess of its expected net realizable value, or is in quantities in excess of expected requirements. In assessing the lower of cost or net realizable value for pre-launch inventory, the Company relies on independent analyses provided by third parties knowledgeable about the range of likely commercial prices comparable to current comparable commercial product. Quarterly, the Company also evaluates whether certain raw materials held in its inventory are expected to reach the end of their estimated shelf-lives based on passage of time, the number of manufacturing cycles they are used in and results of pre-production testing prior to the expected production date, or when resins used in the manufacturing process fail suitability tests. If any of such events occur, the Company may make a determination to record a charge if it is expected that such inventories will become obsolete prior to the expected production date.
Anticipated future sales, shelf lives, and expected approval date are considered when evaluating realizability of capitalized inventory. The shelf-life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventories, the Company considers the product stability data for all of the pre-approval inventory procured or produced to date to determine whether there is adequate shelf-life. When the remaining shelf-life of drug product inventory is less than 12 months, it is likely that it will not be accepted by potential customers. However, as inventories approach their shelf-life expiration, the Company may perform additional stability testing to determine if the inventory is still viable, which can result in an extension of its shelf-life and re-evaluation of the need for and the amount of the previously recorded reserves. Further, in addition to performing additional stability testing, certain raw materials inventory may be sold in its then current condition prior to reaching expiration. If the Company determines that it is not likely that shelf-life may be extended or the inventory cannot be sold prior to expiration, the Company may record a charge to bring inventory to its net realizable value. See Note 3,Inventories, net, for more information.
Research and Development
Research and development costs are expensed as incurred. Clinical trial costs incurred through third parties are expensed commensurate with the contracted work performed. Contingent milestone payments that are due to third parties under research and development collaboration arrangements or other contractual agreements are expensed when the milestone conditions are probable and the payment amount is reasonably estimable. See Note 10,Commitments and Contingencies for additional discussion.
Fair Value of Financial Instruments
The Company’s financial instruments consist primarily of cash, accounts payable and accrued liabilities, and debt. As of May 31, 2024, the carrying value of the Company’s assets and liabilities approximate their fair value due to the short-term maturity of the instruments. Debt is reported at amortized cost in the consolidated balance sheets which approximate fair value. The remaining financial instruments are reported in the consolidated balance sheets at amounts
that approximate current fair values. The fair value hierarchy specifies three levels of inputs that may be used to measure fair value as follows:
| • | 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 which 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 cannot be corroborated with observable market data. |
In accordance with the prescribed accounting guidance, the Company measured the fair value of the liability classified warrants using the fair value hierarchy during the fiscal years ended May 31, 2024, and 2023.
Leases
Operating lease right-of-use (“ROU”) 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 leases on the consolidated balance sheets. Lease ROU assets and liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it would exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
Stock-Based Compensation
U.S. GAAP requires companies to measure the cost of services received in exchange for the award of equity instruments based on their fair value at the date of grant. The related expense is recognized over the period during which services are expected to be performed in exchange for the award (requisite service period), when designated milestones have been achieved or when pre-defined performance conditions are met.
The Company values its stock-based awards using the Black-Scholes option pricing model utilizing assumptions that include stock price volatility, expected term of the award, and risk-free interest rates. The Company estimates forfeitures at the time of grant and makes revisions in subsequent periods, if necessary, if actual forfeitures differ from those estimates. The Company estimated future unvested forfeitures at zero for all periods presented.
Debt
The Company historically issued promissory notes at a discount and incurred direct debt issuance costs. Debt discount and issuance costs are netted against the debt and amortized over the life of the promissory note.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance included in ASC 480,Distinguishing Liabilities from Equity and ASC 815,* Derivatives and Hedging*. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, whether the warrants meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. Warrants that meet all of the criteria for equity classification are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued
or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance and remeasured each balance sheet date thereafter.
Offering Costs
The Company periodically incurs direct incremental costs associated with the sale of shares of common stock and warrants to purchase shares of common stock; refer to Note 6*, Private Placements of Common Stock and Warrants*for additional information. The costs are recorded as a component of equity upon receipt of the proceeds if the security is classified as equity when the sale occurs or expensed as issuance costs if the security is classified as a liability when the sale occurs.
Income Taxes
Deferred taxes are recorded using the asset and liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards; deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax basis. Future tax benefits for net operating loss carryforwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when it is more likely than not that some portion or all the deferred tax assets will not be realized.
The Company follows the provisions of ASC 740-10,Uncertainty in Income Taxes. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there are no unrecognized benefits for all periods presented. The Company has not recognized interest expense or penalties from the implementation of ASC 740-10. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefit in interest expense and penalties in operating expenses.
In accordance with Section 15 of the Internal Revenue Code, the Company utilized a federal statutory rate of 21% for our fiscal 2024 and 2023 tax years. The net tax expense for the fiscal years ended May 31, 2024, and 2023, waszero. As of May 31, 2024, and 2023, the Company has a full valuation allowance as management does not consider it more likely than not that the benefits from the deferred tax assets will be realized.
Basic and Diluted Net Loss Per Share
The Company calculates basic net loss per share by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted-average number of common shares outstanding during the period plus the dilutive effects of potentially dilutive securities outstanding during the period. Potentially dilutive securities include warrants to purchase shares of common stock and stock options. The Company has generated a net loss for all periods presented, therefore diluted net loss per share is the same as basic net loss per share since the inclusion of potentially dilutive securities would be anti-dilutive.
Recent Accounting Pronouncements
In July 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU")2023-03,“Presentation of Financial Statements (Topic 205), Income Statement - Reporting Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation - Stock Compensation (Topic 718): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 120, SEC Staff Announcement at the March 24, 2022 EITF Meeting, and Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280 - General Revision of Regulation S-X: Income or Loss Applicable to Common Stock” (“ASU 2023-03”). This ASU amends various paragraphs in the accounting codification pursuant to the issuance of Commission Staff Bulletin ("SAB") number 120. ASU 2023-03 does not provide any new guidance and is immediately effective. ASU 2023-03 did not have a material impact on the consolidated financial statements.
In October 2023, the FASB issued ASU 2023-06,Disclosure Improvements–*Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative.*The amendments clarify or improve disclosure and presentation requirements on various disclosure areas, including the statement of cash flows, earnings per share, debt, equity, and derivatives. The amendments will align the requirements in the FASB ASC with the SEC’s regulations. The amendments in this ASU will be effective on the date the related disclosures are removed from Regulation S-X or
Regulation S-K by the SEC and will not be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. The Company is currently evaluating the impact of the amendments on its financial statement disclosures.
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. ASU 2023-07 did not have a material impact on the consolidated 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. Inventories, net
Inventories, net of write-offs had azero balance for the fiscal years ended May 31, 2024 and 2023.
During the first quarter of fiscal year 2023, the Company reviewed purchase commitments made by its manufacturing partner, Samsung, under the master agreement between the Company and Samsung, and its vendors for specialized raw materials for which the Company made a prepayment in the amount of approximately $2.7 million in the third quarter of fiscal year 2022, which was recorded as prepaid expenses in the consolidated financial statements as of May 31, 2022.
In October 2022, the Company voluntarily withdrew its rolling BLA submission after concluding that a significant risk existed that the BLA would not receive FDA approval due to the inadequate process and performance by its former CRO around the monitoring and oversight of the clinical data from its trials. Following this decision, the Company’s remaining inventories no longer qualified for capitalization as pre-launch inventories. During the three months ended November 30, 2022, the Company charged-off the remaining raw material resin and work-in-progress bulk product inventories of approximately$16.3 million and $1.7 million, respectively.
Note 4. Accrued Liabilities
The components of accrued liabilities were as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | | | May 31, 2024 | | | May 31, 2023 |
| Compensation and related expense | | $208 | | $335 | ||
| Legal fees and settlement | | | 7 | | | 168 |
| Clinical expense | | | 329 | | | 187 |
| Accrued inventory charges and expenses | | — | | 4,978 | ||
| License fees | | | 1,799 | | | 862 |
| Lease payable | | | 142 | | | 139 |
| Investor proceeds held in escrow | | | 300 | | | — |
| Other liabilities | | | 25 | | | — |
| Total accrued liabilities | | $2,810 | | $6,669 |
As of May 31, 2024 and 2023, the accrued legal fees and settlement balance was primarily related to legal fees.
Note 5. Convertible Instruments and Accrued Interest
Convertible Preferred Stock
The following table presents the number of potentially issuable shares of common stock, should shares of preferred stock and amounts of undeclared and accrued preferred dividends be converted to common stock.
| | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · May 31, 2024 · · May 31, 2023 | ||||||||||||||||||
| (in thousands except conversion rate) · Series B · Series C · Series D · Series B · Series C · Series D | ||||||||||||||||||
| Shares of preferred stock outstanding | | | 19 | | | 6 | | | 9 | | | 19 | | | 6 | | | 9 |
| Common stock conversion rate | | | 10:1 | | | 2,000:1 | | | 1,250:1 | | | 10:1 | | | 2,000:1 | | | 1,250:1 |
| Total shares of common stock if converted | | | 190 | | | 12,670 | | | 10,565 | | | 190 | | | 12,670 | | | 10,565 |
| Undeclared dividends | | $19 | | $— | | $— | | $15 | | $— | | $— | ||||||
| Accrued dividends | | $— | | $3,135 | | $3,656 | | $— | | $2,500 | | $2,808 | ||||||
| Total shares of common stock if dividends converted | | | 38 | | | 6,270 | | | 7,312 | | | 30 | | | 5,000 | | | 5,616 |
Under the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), dividends on its outstanding shares of Series B Convertible Preferred Stock (the “Series B Preferred Stock”) may be paid in cash or shares of the Company’s common stock at the 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. Shares of common stock presented in the table above represent the number of shares that would have been issued had the dividend been paid in shares of the Company’s common stock as of the end of each presented period; undeclared dividends of Series C Preferred Stock and Series D Preferred Stock are accrued as of May 31, 2024. 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. As of May 31, 2024, the Company had an accumulated deficit of approximately $891.5 million and had net loss in each fiscal year since inception and, therefore, is prohibited from paying any dividends, whether in cash, other property, or in shares of capital stock. Refer to the discussion below for additional information.
Series B Convertible Preferred Stock
Each share of the Series B Preferred Stock is convertible intoten shares of the Company’s common stock. Dividends are payable to the Series B Preferred stockholders when and as declared by the Board at the rate of $0.25 per share per annum. Such dividends are cumulative and accrue whether or not declared and whether or not there are any profits, surplus, or other funds or assets of the Company legally available therefor. At the option of the Company, dividends on the Series B Preferred Stock may be paid in cash or restricted shares of the Company’s common stock, valued at $0.50 per share. The preferred shareholders can only convert their shares to shares of common stock if the Company has sufficient authorized shares of common stock at the time of conversion. The Series B Preferred Stock has liquidation preferences over the common shares at $5.00 per share, plus any accrued and unpaid dividends. Except as provided by law, the Series B holders have no voting rights. The Company does not accrue dividends on Series B preferred stock until such dividends are declared.
Series C Convertible Preferred Stock
The Series C Certificate of Designation provides, among other things, that holders of Series C Preferred Stock shall be entitled to receive, when and as declared by the Board and out of any assets at the time legally available therefor, cumulative dividends at the rate of ten percent (10%) per share per annum of the stated value of the Series C Preferred Stock, which is $1,000 per share (the “Series C Stated Value”). Any dividends paid by the Company will be paid to the holders of Series C Preferred Stock prior and in preference to any payment or distribution to holders of common stock. Dividends on the Series C Preferred Stock are cumulative, and will accrue and be compounded annually, whether or not declared and whether or not there are any profits, surplus, or other funds or assets of the Company legally available therefor. There are no sinking fund provisions applicable to the Series C Preferred Stock. The Series C Preferred Stock does not have redemption rights. Dividends, if declared by the Board, are payable to holders in arrears on December 31 of each year. Subject to the provisions of applicable Delaware law, the holder may elect to be paid in cash or in restricted
shares of common stock, with the number of shares to be based on the conversion price then in effect. In the event of liquidation, dissolution, or winding up of the Company, the holders of Series C Preferred Stock will be entitled to receive, on a pari passu basis with the holders of the Series D Preferred Stock and in preference to any payment or distribution to any holders of the Series B Preferred Stock or common stock, an amount per share equal to the Series C Stated Value plus the amount of any accrued and unpaid dividends. If, at any time while the Series C Preferred Stock is outstanding, the Company effects a reorganization, merger or consolidation of the Company, sale of substantially all of its assets, or other specified transaction (each, as defined in the Series C Certificate of Designation, a “Fundamental Transaction”), a holder of the Series C Preferred Stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series C Preferred Stock immediately prior to the Fundamental Transaction. Each share of Series C Preferred Stock is convertible at any time at the holder’s option into that number of fully paid and nonassessable shares of common stock determined by dividing the Series C Stated Value by the conversion price of $0.50 (subject to adjustment as set forth in the Series C Certificate of Designation). No fractional shares will be issued upon the conversion of the Series C Preferred Stock. Except as otherwise provided in the Series C Certificate of Designation or as otherwise required by law, the Series C Preferred Stock has no voting rights.
Series D Convertible Preferred Stock
The Series D Certificate of Designation provides, among other things, that holders of Series D Preferred Stock shall be entitled to receive, when and as declared by the Company’s Board of Directors and out of any assets at the time legally available therefor, cumulative dividends at the rate of ten percent (10%) per share per annum of the stated value of the Series D Preferred Stock, which is $1,000 per share (the “Series D Stated Value”). Any dividends paid by the Company will first be paid to the holders of Series D Preferred Stock prior and in preference to any payment or distribution to holders of common stock. Dividends on the Series D Preferred Stock are cumulative, and will accrue and be compounded annually, whether or not declared and whether or not there are any profits, surplus, or other funds or assets of the Company legally available therefor. There are no sinking fund provisions applicable to the Series D Preferred Stock. The Series D Preferred Stock does not have redemption rights. Dividends, if declared by the Board, are payable to holders in arrears on December 31 of each year. Subject to the provisions of applicable Delaware law, the holder may elect to be paid in cash or in restricted shares of common stock, with the number of shares to be based on the conversion price then in effect. In the event of liquidation, dissolution, or winding up of the Company, the holders of Series D Preferred Stock will be entitled to receive, on a pari passu basis with the holders of the Series C Preferred Stock and in preference to any payment or distribution to any holders of the Series B Preferred Stock, $0.001 par value per share, or common stock, an amount per share equal to the Series D Stated Value plus the amount of any accrued and unpaid dividends. If, at any time while the Series D Preferred Stock is outstanding, the Company effects any reorganization, merger or consolidation of the Company, sale of substantially all of its assets, or other specified transaction (each, as defined in the Series D Certificate of Designation, a “Fundamental Transaction”), a holder of the Series D Preferred Stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series D Preferred Stock immediately prior to the Fundamental Transaction. Each share of Series D Preferred Stock is convertible at any time at the holder’s option into that number of fully paid and nonassessable shares of common stock determined by dividing the Series D Stated Value by the conversion price of $0.80 (subject to adjustment as set forth in the Series D Certificate of Designation). No fractional shares will be issued upon the conversion of the Series D Preferred Stock. Except as otherwise provided in the Series D Certificate of Designation or as otherwise required by law, the Series D Preferred Stock has no voting rights.
Convertible Notes and Accrued Interest
The outstanding balance of convertible notes, the terms of which are described in more detail below, including accrued interest, were as follows:
| | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · May 31, 2024 · · May 31, 2023 | |||||||||||||||||||||
| (in thousands) · April 2, 2021 Note · April 23, 2021 Note · Total · April 2, 2021 Note · April 23, 2021 Note · · · Placement Agent Notes · · Total | |||||||||||||||||||||
| Convertible notes payable outstanding principal | | $2,831 | | $27,369 | | $30,200 | | $6,081 | | $29,369 | | $1,000 | | $36,450 | |||||||
| Less: Unamortized debt discount and issuance costs | | | (45) | | | (362) | | | (407) | | | (211) | | | (822) | | | (286) | | | (1,319) |
| Convertible notes payable, net | | | 2,786 | | | 27,007 | | | 29,793 | | | 5,870 | | | 28,547 | | | 714 | | | 35,131 |
| Accrued interest on convertible notes | | | 4,634 | | | 10,593 | | | 15,227 | | | 3,804 | | | 6,789 | | | 5 | | | 10,598 |
| Outstanding convertible notes payable, net and accrued interest | | $7,420 | | $37,600 | | $45,020 | | $9,674 | | $35,336 | | $719 | | $45,729 | |||||||
Changes in the outstanding balance of convertible notes, including accrued interest, were as follows:
| | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (in thousands) · · April 2, 2021 Note · · April 23, 2021 Note · · · Placement Agent Notes · · · Short-Term Notes · · Total | |||||||||||||||
| Outstanding balance at May 31, 2023 | | $9,674 | | $35,336 | | $719 | | $— | | $45,729 | |||||
| Consideration received | | | — | | | — | | | 975 | | | 698 | | | 1,673 |
| Amortization of issuance discount and costs | | | 166 | | | 460 | | | 583 | | | 302 | | | 1,511 |
| Interest expense | | | 830 | | | 3,804 | | | 18 | | | 7 | | | 4,659 |
| Fair market value of shares and warrants exchanged for repayment | | | (4,737) | | | (2,513) | | | (4,379) | | | (2,558) | | | (14,187) |
| Difference between market value ofcommon shares and reduction of principal | | | 1,487 | | | 513 | | | 2,084 | | | 1,551 | | | 5,635 |
| Outstanding balance at May 31, 2024 | | $7,420 | | $37,600 | | $— | | $— | | $45,020 | |||||
Convertible Note – April 2, 2021 Note
On April 2, 2021, the Company entered into a securities purchase agreement pursuant to which the Company issued a secured convertible promissory note with atwo-year term in the initial principal amount of $28.5 million (the “April 2, 2021 Note”). The maturity date has been extended an additionaltwo years to April 2025. SeeApril 2, 2021 and April 23, 2021 Note Extensions below. The Company received consideration of $25.0 million, reflecting an original issue discount of $3.4 million and issuance costs of $0.1 million.
Interest accrues at an annual rate of 10% on the outstanding balance, with the rate increasing to the lesser of 22% per annum or the maximum rate permitted by applicable law upon occurrence of an event of default. In addition, upon any event of default, the investor may accelerate the outstanding balance payable under the April 2, 2021 Note; upon such acceleration, the outstanding balance will increase automatically by 15%,10%, or 5%, depending on the nature of the event of default. The events of default are listed in Section 4 of the April 2, 2021 Note filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on April 8, 2021, and listed as Exhibit 4.13 in Item 15 to this report. The April 2, 2021 Note is secured by all the assets of the Company, excluding the Company’s intellectual property.
Pursuant to the terms of the securities purchase agreement and the April 2, 2021 Note, the Company must obtain the investor’s consent before assuming additional debt with aggregate net proceeds to the Company of less than $50.0 million. In the event of any such approval, the outstanding principal balance of the April 2, 2021 Note will increase automatically by 5% upon the issuance of such additional debt.
The investor may convert all or any part of the outstanding balance of the April 2, 2021 Note into shares of common stock at an initial conversion price of $10.00 per share upon five trading days’ notice, subject to certain adjustments and volume and ownership limitations. In addition to standard anti-dilution adjustments, the conversion price of the April 2, 2021 Note is subject to full-ratchet anti-dilution protection, pursuant to which the conversion price will be automatically reduced to equal the effective price per share in any new offering by the Company of equity securities that have
registration rights, are registered, or become registered under the Securities Act, as amended. The April 2, 2021 Note provides for liquidated damages upon failure to deliver common stock within specified timeframes and requires the Company to maintain a share reservation of 6.0 million shares of common stock. The investor may redeem any portion of the note, at any time beginningsix months after the issue date upon three trading days’ notice, subject to a maximum monthly redemption amount of $3.5 million. The April 2, 2021 Note requires the Company to satisfy its redemption obligations in cash within three trading days of the Company’s receipt of such notice. The Company may prepay the outstanding balance of the note, in part or in full, plus a 15% premium, at any time upon 15 trading days’ notice.
In addition, beginning in May 2021 and for each of the following five months, the Company was obligated through November 2021, at the discretion of the noteholder, to reduce the outstanding balance of the April 2, 2021 Note by $7.5 million per month. Payments under the April 23, 2021 Note, described below, could be applied toward the payment of each monthly debt reduction amount. These payments were not subject to the 15% prepayment premium, which would otherwise have been triggered if the Company were to make payments against such notes exceeding the allowed maximum monthly redemption amount.
The conversion feature of the April 2, 2021 Note was analyzed under ASC 815,Derivatives and Hedging, to determine if it achieved equity classification or required bifurcation as a derivative instrument. The embedded conversion feature was considered indexed to the Company’s own stock and met the conditions for equity classification. Accordingly, the embedded conversion feature did not require bifurcation from the host instrument. The Company determined there wasno beneficial conversion feature since the effective conversion rate was greater than the market value of the Company’s common stock upon issuance. Certain default put provisions were considered not to be clearly and closely related to the host instrument, but the Company concluded that the value of these default put provisions was de minimis. The Company evaluates the value of the default put provisions each reporting period to determine if the value becomes material to the financial statements.
During the fiscal year ended May 31, 2024, in satisfaction of redemptions, the Company and the April 2, 2021 Noteholder entered intosix exchange agreements, pursuant to which the April 2, 2021 Note was partitioned into new notes (the “Partitioned Notes”) with an aggregate principal amount of approximately $3.3 million, which was exchanged concurrently with the issuance of an aggregate amount of approximately 20.4 million shares of common stock. The outstanding balance of the April 2, 2021 Note was reduced by the Partitioned Notes to a principal amount of $2.8 million. The Company accounted for the Partitioned Notes and exchange settlement as an induced conversion, and, accordingly, in the fiscal years ended May 31, 2024 and 2023, the Company recorded a non-cash loss on convertible debt induced conversion of $4.7 million and $5.3 million, respectively.
Convertible Note – April 23, 2021 Note
On April 23, 2021, the Company entered into a securities purchase agreement pursuant to which the Company issued a secured convertible promissory note with atwo-year term to an institutional accredited investor affiliated with the holder of the April 2, 2021 Note in the initial principal amount of $28.5 million (the “April 23, 2021 Note”). The maturity date has been extended anothertwo years to April 2025. SeeApril 2, 2021 and April 23, 2021 Note Extensions below. The Company received consideration of $25.0 million, reflecting an original issue discount of $3.4 million and issuance costs of $0.1 million. The April 23, 2021 Note is secured by all the assets of the Company, excluding the Company’s intellectual property.
Interest accrues at an annual rate of 10% on the outstanding balance of the April 23, 2021 Note, with the rate increasing to the lesser of 22% per annum or the maximum rate permitted by applicable law upon the occurrence of an event of default. In addition, upon any event of default, the investor may accelerate the outstanding balance payable under the April 23, 2021 Note; upon such acceleration, the outstanding balance will increase automatically by 15%,10%, or 5%, depending on the nature of the event of default. The events of default are listed in Section 4 of the April 23, 2021 Note filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on April 29, 2021, and listed as Exhibit 4.14 in Item 15 to this report.
The investor may convert all or any part of the outstanding balance into shares of common stock at an initial conversion price of $10.00 per share upon five trading days’ notice, subject to certain adjustments and volume and ownership limitations specified in the April 23, 2021 Note. In addition to standard anti-dilution adjustments, the conversion price of the 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. The April 23, 2021 Note provides for liquidated damages upon failure to deliver common stock within specified timeframes and requires the Company to maintain a share reservation of 6.0 million shares of common stock.
The investor may redeem any portion of the April 23, 2021 Note, at any time beginningsix months after the issue date, upon three trading days’ notice, subject to a maximum monthly redemption amount of $7.0 million. The April 23, 2021 Note requires the Company to satisfy its redemption obligations in cash within three trading days of the Company’s receipt of such notice. The Company may prepay the outstanding balance of the April 23, 2021 Note, in part or in full, plus a 15% premium, at any time upon 15 trading days’ notice.
Pursuant to the terms of the securities purchase agreement and the April 23, 2021 Note, the Company must obtain the investor’s consent before assuming additional debt with aggregate net proceeds to the Company of less than $75.0 million. In the event of any such approval, the outstanding principal balance of the April 23, 2021 Note will increase automatically by 5% upon the issuance of such additional debt.
The conversion feature in the April 23, 2021 Note was analyzed under ASC 815,Derivatives and Hedging, to determine if it achieved equity classification or required bifurcation as a derivative instrument. The embedded conversion feature was considered indexed to the Company’s own stock and met the conditions for equity classification. Accordingly, the embedded conversion feature does not require bifurcation from the host instrument. The Company determined there wasno beneficial conversion feature since the effective conversion rate was greater than the market value of the Company’s common stock upon issuance. Certain default put provisions were not considered to be clearly and closely related to the host instrument, but the Company concluded that the value of these default put provisions was de minimis. The Company evaluates the value of the default put provisions each reporting period to determine if the value becomes material to the financial statements.
During the fiscal year ended May 31, 2024, in satisfaction of redemptions, the Company and the April 23, 2021 Noteholder entered into four exchange agreements, pursuant to which the April 23, 2021 Note was partitioned into new notes (the “Partitioned Notes”) with an aggregate principal amount of $2.0 million, which was exchanged concurrently with the issuance of an aggregate amount of approximately 13.9 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 $27.4 million. The Company accounted for the Partitioned Notes and exchange settlement as an induced conversion, and, accordingly, in the fiscal year ended May 31, 2024 the Company recorded a non-cash loss on convertible debt induced conversion of $1.9 million. No non-cash loss on convertible debt induced conversion related to the April 23, 2021 Note was recorded in the fiscal year ended May 31, 2023.
The holders of the April 2 and April 23 Notes have waived provisions in the notes that would have resulted in the imposition of a default interest rate, a downward adjustment in the conversion price, or any other default, breach, or imposition of a penalty. The related transactions consisted of the issuance of additional notes, and shares of common stock and warrants issued through a placement agent.
April 2, 2021 Note and April 23, 2021 Note Extensions
On April 10, 2023 the Company and the April 2, 2021 and April 23, 2021 noteholders entered into an amendment for each note that extended the maturity date an additionaltwo years for each note. In exchange, the Company agreed to pay the noteholders an extension fee equal to two and one-half percent (2.5%) of the outstanding balance of each note as of April 10, 2023. As a result, the balances of the April 2, 2021 Note and April 23, 2021 increased by$0.3 million and$0.9 million, respectively.
The Company accounted for the note extensions as an increase to the discount on the convertible notes payable and is amortizing the note extension fee over the remaining term of the notes.
Placement Agent Notes
During the period April through June 2023, the Company entered into securities purchase agreements pursuant to which the Company issued secured promissory notes bearing interest at a rate of 6.0% and with an 18-month term to accredited investors through a placement agent (“Placement Agent Notes”) for a total principal amount of approximately$2.3 million, of which$1.3 million was sold in June 2023. The Placement Agent Notes were secured by the net cash recovery, if any, by the Company in its dispute with Amarex and provided the investors with a right to convert the unpaid principal and accrued but unpaid interest into shares of common stock upon the occurrence of an event of default. The Placement Agent Notes had maturity dates during the fiscal year ending May 31, 2025.
In connection with the sale in June 2023, the Company issued warrants to investors to purchase approximately 1.3 million shares of common stock with athree-year term and an exercise price of$0.50 per share. The net proceeds from the sale of the Placement Agent Notes in June of approximately$1.1 million reflect issuance costs of approximately$0.2 million. The Company also issued warrants to purchase approximately 0.4 million shares of common stock to the placement agent with aten-year term and an exercise price of$0.26 per share, which the Company accounted for as additional issuance costs related to the sale of Placement Agent Notes in June 2023. The Company allocated the proceeds between the liability-classified Placement Agent Notes and the equity-classified warrants based on their relative fair values.
During June 2023, an amendment was entered into with the investors of the Placement Agent Notes, which stated that the principal amount and accrued but unpaid interest on the notes would be converted into shares of common stock and warrants as of the first closing of a subsequent private placement of common stock and warrants through a placement agent. The deemed purchase price of a unit ofone share plusone warrant was fixed at 90% of the lower of the intraday volume weighted average price (“VWAP”) on the date of the first closing and last closing of the private placement, while the exercise price of the warrants was set at $0.306 per share, compared to $0.50 per share in the original private placement.
In July 2023, the first closing of the subsequent private placement of common stock and warrants through a placement agent occurred. Therefore, the Placement Agent Notes were converted into units with the same pricing as the private placement described below in Note 6,Private Placements of Common Stock and Warrants – Private placements of common stock and warrants through placement agent. The$2.1 million difference in fair value between the shares and warrants and the principal amount of the Placement Agent Notes was accounted for as a loss on note extinguishment. See Note 6,Private Placements of Common Stock and Warrantsfor additional information.
- Short-term Notes*
During November and December 2023, the Company issued unsecured promissory notes bearing interest at a rate of 10% to accredited investors under a securities purchase agreement through a placement agent (“Short-term Notes”) for a total principal amount of$1.0 million. The Short-term Notes’ maturity date was June 7, 2024. The Company also agreed to issue warrants at the final closing of the sale of Short-term Notes to purchaseone share of common stock for each dollar of principal amount of Short-term Notes sold. The warrants have afive-year term and an exercise price of$0.35 per share. The net proceeds from the sale of the Short-term Notes of$0.9 million reflect issuance costs of approximately$0.1 million. The Company allocated the proceeds between the liability-classified Short-term Notes and the equity-classified warrants based on their relative fair values.
The Company also agreed to issue warrants to purchase shares of common stock to the placement agent with aten-year term, with the number of warrants and the exercise price of the warrants to be determined by the share price on the final closing date of the sale of Short-term Notes. The Company accounted for the warrants to be issued to the placement agent as additional issuance costs. See Note 6,Private Placements of Common Stock and Warrantsfor additional information.
In December 2023, the principal amount and accrued but unpaid interest on the notes were converted into units consisting of shares of common stock and warrants as of the first closing of a private placement of common stock and warrants through a placement agent, with a conversion based on an amount equal to a 20% discount to the price at which the units were sold in the private placement. The$1.6 million difference in fair value between the shares and warrants and the principal amount of the Short-term Notes was accounted for as a loss on note extinguishment. See Note 6,Private Placements of Common Stock and Warrantsfor additional information.
Note 6. Private Placements of Common Stock and Warrants
Approval of increase in authorized common stock
On November 9, 2023, at the Company’s annual stockholders’ meeting, the Company’s stockholders approved a proposal to increase the total number of authorized shares of common stock from 1.35 billion shares to 1.75 billion shares.
Liability classified warrants
From June 24, 2022 through August 31, 2022, the Company had insufficient authorized common stock to reserve for the shares underlying the Surety Backstop warrants and warrants issued to a placement agent in connection with the June 2022 offering. After approval by the Company’s stockholders of an increase to the Company’s authorized common stock, on August 31, 2022, sufficient shares were authorized to cover the shares underlying the warrants. Given that the Company did not have a sufficient number of authorized shares for the instruments at the time they were issued, the Company accounted for such warrants issued from June 24, 2022 through August 2022 as liability classified warrants consistent with ASC 815,Derivatives and Hedging.
On December 1, 2022, the Company entered into the second amendment of the Surety Bond Backstop Agreement which included the issuance ofa warrant covering up to 7.5 million shares of common stock with an exercise price of$0.10 per share, with the ultimate number of shares to be covered by the second warrant to be calculated based on a formula relating to how quickly the Company relieved the balance of cash collateral pledged by the Indemnitors. On February 28, 2023, the warrant was determined to cover 7.5 million shares of common stock. As the settlement amount of shares of common stock underlying the warrant was variable, the Company accounted for such warrant as a liability classified warrant consistent with ASC 815,Derivatives and Hedging, until the number of shares underlying the warrant was determined, at which point the warrant became equity classified.
During April and May 2023, the Company sold Placement Agent Notes through a placement agent. See Note 5,Convertible Instruments and Accrued Interest – Placement Agent Notes. The Company agreed to issue warrants to the placement agent as part of the issuance costs with an exercise price that was not determined until the final closing date. As the exercise price of the warrants was to be fixed based on the final terms of the offering, the Company accounted for the warrants as a liability-classified warrant beginning on the initial closing date until the final closing date. The value of the warrants on May 31, 2023, was recorded as a derivative liability on the balance sheet, and the change in the fair value of the warrants was recorded as a gain or loss on derivatives. On June 23, 2023, the final closing of the Placement Agent Notes occurred, and the fair value of the warrants became equity classified.
On July 31, 2023, the Placement Agent Notes were converted into units that had similar terms to units being offered in a private placement of shares and warrants through a placement agent that commenced in July 2023. SeePrivate placement of common stock and warrants through placement agent below. As the unit price was not determinable until the final closing date of the subsequent private placement, the units related to the conversion of the Placement Agent Notes were recorded as a liability and at fair value. On October 23, 2023, the private placement was concluded, which finalized the unit purchase price at$0.16, and the fair value of the units became equity-classified.
During November 2023, in connection with the issuance of the Short-term Notes described in Note 5,Convertible Instruments and Accrued Interest – Short-term Notes, the Company agreed to issue warrants to the placement agent as part of the issuance costs, with the ultimate number of warrants and exercise price to be determined as of the final closing date. The value of the warrants was recorded as a derivative liability on the balance sheet until the final closing date in December 2023, and the change in the fair value of the warrants was recorded as a gain or loss on derivatives.
On December 29, 2023, the Short-term Notes were converted into units that had similar terms to units being offered in a private placement of shares and warrants through a placement agent. SeePrivate placement of common stock and warrants
through placement agent below. As the unit price was not determinable until the final closing date of the subsequent private placement, the units related to the conversion of the Placement Agent Notes were recorded as a liability and at fair value. The change in the fair value of the units was recorded as a gain or loss on derivatives. On May 3, 2024, the private placement was concluded, which finalized the unit purchase price at$0.10, and the fair value of the units became equity-classified.
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.
As of May 31, 2024, in accordance with ASC 815,Derivatives and Hedging, the Company reclassified warrants to equity when the warrants no longer qualified as liabilities. The Company recorded a loss on derivatives of approximately $0.2 million and $8.8 million in the fiscal years ended May 31, 2024 and 2023, respectively, due to a change in fair market value of the liability classified shares of common stock and warrants. The table below presents a reconciliation of the beginning and ending balances for liabilities measured at fair value as of May 31, 2022, and during the fiscal years ended May 31, 2023 and 2024:
| | | |
|---|---|---|
| (in thousands) · Liability Classified Warrants | ||
| Balance at May 31, 2022 | $— | |
| Classified as liability | | 16,664 |
| Reclassified as equity | | (25,335) |
| Loss on derivative due to change in fair market value | | 8,750 |
| Balance at May 31, 2023 | | 79 |
| Classified as liability | 6,970 | |
| Reclassified as equity | (7,285) | |
| Loss on derivative due to change in fair market value | 236 | |
| Balance at May 31, 2024 | $— | |
The Company used a Black-Scholes valuation model to estimate the value of the liability classified warrants using assumptions presented in the table below. The Black-Scholes valuation model was used because management believes it reflects all the assumptions that market participants would likely consider in negotiating the transfer of the warrant. The Company’s derivative liability is classified within Level 3.
The Company estimated the fair value of the warrant derivatives using the following assumptions:
| | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · Inputs at Liability Classification · Inputs at Equity Classification | ||||||||||||||||
| | | Backstop | | Backstop | | Placement Agent | | Backstop | | Backstop | | Backstop | | Placement | | Backstop |
| | | Warrant #1 | | Warrant #2 | | Warrants | | Warrant #3 | | Warrant #1 | | Warrant #2 | | Agent Warrants | | Warrant #3 |
| Fair value of underlying stock | | $ 0.44 | | $ 0.42 | | $ 0.44 | | $ 0.35 | | $ 0.52 | | $ 0.52 | | $ 0.52 | | $ 0.32 |
| Risk free rate | | 3.17% | | 3.06% | | 3.13% | | 3.68% | | 3.34% | | 3.31% | | 3.16% | | 4.18% |
| Expected term (in years) | | 4.65 | | 5.00 | | 10.00 | | 5.00 | | 4.46 | | 4.88 | | 9.82 | | 4.76 |
| Stock price volatility | | 110.20% | | 109.49% | | 95.99% | | 124.36% | | 117.29% | | 113.59% | | 95.87% | | 126.67% |
| Expected dividend yield | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% |
| | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · · · | ||||||||||||||||
| · April · · Inputs at Liability Classification · · Inputs at Equity Classification | ||||||||||||||||
| | | Placement | | July | | November | | December | | | | July | | November | | December |
| | | Agent | | Note | | Placement | | Note | | April | | Note | | Placement | | Note |
| | | warrants at | | conversion | | Agent | | conversion | | Placement | | conversion | | Agent conversion | | conversion |
| | | May 31, 2023 | | warrants | | warrants | | warrants | | Warrants | | warrants | | warrants | | warrants |
| Fair value of underlying stock | | $ 0.26 | | $ 0.21 | | $ 0.18 | | $ 0.20 | | $ 0.27 | | $ 0.17 | | $ 0.30 | | $ 0.15 |
| Risk free rate | | 3.64% | | 4.18% | | 4.42% | | 3.84% | | 3.74% | | 4.81% | | 4.14% | | 4.48% |
| Expected term (in years) | | 10.00 | | 5.00 | | 10.00 | | 5.00 | | 10.00 | | 5.00 | | 10.00 | | 5.00 |
| Stock price volatility | | 97.90% | | 124.55% | | 95.82% | | 124.25% | | 97.45% | | 124.70% | | 96.18% | | 124.04% |
| Expected dividend yield | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% | | 0.00% |
Private placement of common stock and warrants through placement agent
In July 2023, the Company commenced a private placement of units consisting of common stock and warrants to accredited investors through a placement agent. Each unit sold included a fixed combination ofone share of common stock andone warrant to purchaseone share of common stock. The purchase price per unit was $0.16, equal to 90% of the intraday VWAP of the common stock as of the last closing on September 27, 2023. From July through September 2023, the Company sold a total of approximately 21.5 million units for a total of approximately $3.0 million of proceeds, net of issuance costs. The Company classified the securities issued in the private placement as a liability until the final close, when it was reclassified as equity. As part of the offering, the Company issued approximately 21.5 million warrants to investors, with each such warrant having afive-year term and an exercise price of $0.50 per share. The warrants were immediately exercisable. In connection with the above, the Company paid the placement agent a total cash fee of approximately $0.4 million, equal to 12% of the gross proceeds of the offering, as well as a one-time fee for expenses of $5,000, and issued to the placement agent and its designees a total of approximately 3.2 million warrants with an exercise price of $0.16 per share and aten-year term, representing 15% of the total number of shares of common stock sold in the offering.
Based on contractual payment terms, the private placement transactions above are considered convertible debt instruments prior to final settlement, and the option to enter a final closing that would lower the purchase price is considered a share-settled redemption feature. Therefore, the approximately $0.9 million of cash and non-cash issuance costs associated with such issuances were capitalized and subsequently recognized through the statement of operations as interest expense on the final closing date. As the VWAP of the final closing was lower than the VWAP on the initial closing, the share-settled redemption feature was triggered, and the Company recorded a $2.4 million non-cash loss on note extinguishment.
In addition, approximately $2.3 million of principal and interest of the Placement Agent Notes were converted into approximately 14.3 million units with the same terms as described above except for a warrant exercise price of $0.306. See Note 5,Convertible Instruments and Accrued Interest – Placement Agent Notes, andLiability-classified equity instruments above for additional information.
In December 2023, the Company commenced a private placement of units consisting of common stock and warrants to accredited investors through a placement agent. Each unit sold included a fixed combination ofone share of common stock andone warrant to purchaseone share of common stock. The purchase price per unit was $0.13 equal to 90% of the intraday VWAP of the common stock as of the last closing on May 3, 2024. From December 2023 through May 2024, the Company sold a total of approximately 52.6 million units for a total of approximately $5.9 million of proceeds, net of issuance costs. The Company classified the securities to be issued in the private placement as a liability until the final close when it was reclassified as equity. As part of the offering, the Company issued approximately 52.6 million warrants to investors, with each such warrant having afive-year term and an exercise price of $0.21 per share (reduced
from $0.35 per share as discussed below). The warrants were immediately exercisable when issued on the final closing date. In connection with the above, the Company paid the placement agent a total cash fee of approximately $0.9 million, equal to 13% of the gross proceeds of the offering, as well as a one-time fee for expenses of $5,000, and issued to the placement agent and its designees a total of approximately 7.9 million warrants with an exercise price of $0.13 per share and aten-year term, representing 15% of the total number of shares of common stock sold in the offering.
Based on contractual payment terms, the private placement transactions above are considered convertible debt instruments prior to final settlement, and the option to enter a final closing that would lower the purchase price is considered a share-settled redemption feature. Therefore, the approximately $1.9 million of cash and non-cash issuance costs associated with such issuances were capitalized and subsequently recognized through the statement of operations as interest expense on the final closing date. As the VWAP of the final closing was lower than the VWAP on the initial closing, the share-settled redemption feature was triggered, and the Company recorded a $7.3 million non-cash loss on note extinguishment. The exercise price for the warrants included in the private placement was lowered from $0.35 per share to $0.21 per share. The exercise price modification resulted in the Company recognizing a $0.1 million non-cash discount on convertible notes.
In addition, approximately $1.0 million principal and interest of the Placement Agent Notes were converted into approximately 10.1 million units with the same terms as discussed above. See Note 5,Convertible Instruments and Accrued Interest – Short-term Notes, andLiability-classified equity instruments above for additional information.
Later in May 2024, the Company sold a total of approximately 1.5 million units for a total of approximately$0.2 million in proceeds, net of offering costs, as part of a follow-on offering with the same terms as the units sold in December 2023 through May 2024. As part of the offering, the Company issued approximately 1.5 million warrants to investors, with each such warrant having afive-year term and an exercise price of$0.21 per share. The warrants were immediately exercisable. In connection with the above, the Company paid the placement agent a total cash fee of approximately $26.0 thousand, equal to 13% of the gross proceeds of the offering.
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, 2022 | 73,248 | | $0.59 | 3.18 | | $352 |
| Granted | 201,771 | | $0.33 | | | |
| Exercised | (6,207) | | $0.63 | | | 758 |
| Forfeited, expired, and cancelled | (8,902) | | $0.75 | | | |
| Warrants outstanding at May 31, 2023 | 259,910 | | $0.37 | 4.57 | | $7,276 |
| Granted | 115,582 | | $0.28 | | | |
| Exercised | (3,000) | | $0.10 | | | 480 |
| Forfeited, expired, and cancelled | (11,047) | | $0.63 | | | |
| Warrants outstanding at May 31, 2024 | 361,445 | | $0.34 | 4.21 | | $2,697 |
| Warrants outstanding and exercisable at May 31, 2024 | 361,445 | | $0.34 | 4.21 | | $2,697 |
Warrant exercises
During the fiscal year ended May 31, 2024, the Company issued approximately 3.0 million shares of common stock in connection with the exercise of an equal number of warrants. The stated exercise price was$0.10 per share, which resulted in aggregate gross proceeds of approximately$0.3 million.
Note 7. Equity Incentive Plan
Equity Incentive Plan
As of May 31, 2024, the Company hadone active equity incentive plan, theCytoDyn Inc. Amended and Restated 2012 Equity Incentive Plan(the “2012 Plan”). The 2012 Plan contains an “evergreen provision” whereby the total number of shares available to be issued automatically increases annually on the first day of each fiscal year in an amount equal to 1.0% of the total outstanding shares on the last day of the prior fiscal year, unless the Board determines otherwise before the fiscal year end. As of May 31, 2024, the 2012 Plan covered a total of 56.3 million shares of common stock.
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, 2022 | 17,457 | | $1.53 | 7.79 | | $— |
| Granted | 12,417 | | $0.41 | | | |
| Exercised | — | | $— | | | |
| Forfeited, expired, and cancelled | (10,051) | | $1.16 | | | |
| Options outstanding at May 31, 2023 | 19,823 | | $0.99 | 7.87 | | $— |
| Granted | 14,251 | | $0.21 | | | |
| Exercised | — | | $— | | | |
| Forfeited, expired, and cancelled | (8,225) | | $0.87 | | | |
| Options outstanding at May 31, 2024 | 25,849 | | $0.60 | 7.77 | | $— |
| Options outstanding and exercisable at May 31, 2024 | 19,679 | | $0.71 | 7.25 | | $— |
The fair value of the equity awards granted is estimated using the Black-Scholes option-pricing model based on the closing stock prices at the grant date and the assumptions specific to the underlying award. Expected volatility assumptions are based on the historical volatility of the Company’s common stock. The expected term assumption is based on the contractual and vesting term of the equity award. The risk-free interest rate is based on the U.S. Treasury yield curve with a maturity equal to the expected life assumed at the grant date. The following table summarizes the assumptions used in the determination of fair value:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Years ended May 31, | ||||||
| · · 2024 · 2023 | ||||||
| Expected Volatility | | 108.6% - 115.7% | | 99.2% - 112.7% | ||
| Weighted-Average Volatility | | 112.24% | | 107.06% | ||
| Expected Dividends | | - | % | | - | % |
| Expected Term (In years) | | 5.1 - 6.0 | | | 5.0 - 6.1 | |
| Risk-Free Rate | | 3.96% | | 3.83% | ||
In the fiscal years ended May 31, 2024, and 2023, stock-based compensation expense related to equity instruments totaled $2.4 million and $4.2 million, respectively; stock-based compensation expense is presented in general and administrative expense in the Company’s consolidated statements of operations. The grant date fair value of options vested during the same periods was approximately $3.3 million and $4.9 million, respectively. As of May 31, 2024,
there was approximately $0.9 million of unrecognized compensation expense related to share-based payments for unvested options, which is expected to be recognized over a weighted-average period of approximately 1.9 years.
During the fiscal year ended May 31, 2024, the Company granted stock options covering a total of approximately 14.3 million shares of common stock to directors, employees, and consultants, with exercise prices ranging between $0.21 and $0.26 per share. Of the current year options, approximately 0.5 million options vest when performance conditions are completed, approximately 5.7 million vest over four years, and approximately 4.0 million vest overone year, with a ten-year term. 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 grant date fair values of the stock options ranged between $0.15 and $0.17 per share. As of May 31, 2024, and May 31, 2023, there were approximately 19.7 million and 12.0 million vested stock options and approximately 6.1 million and 7.8 million unvested stock options outstanding, respectively.
RSUs and PSUs
The 2012 Plan provides for equity instruments, such as RSUs and PSUs, which grant the right to receive a specified number of shares over a specified period of time. RSUs and PSUs are service-based awards that vest according to the terms of the grant. PSUs have performance-based payout conditions.
The following table summarizes the Company’s RSU and PSU activity:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | | | | | | Weighted average |
| · · Number of · · Weighted average · · remaining contractual | |||||||
| (shares in thousands) · RSUs and PSUs (1) · grant date fair value · · life in years | |||||||
| Unvested RSUs and PSUs at May 31, 2022 | 300 | | $3.12 | | 0.58 | ||
| RSUs and PSUs granted | 1,293 | | | 0.58 | | | |
| RSUs and PSUs forfeited | (150) | | | 3.12 | | | |
| RSUs and PSUs vested | (150) | | | 3.12 | | | |
| Unvested RSUs and PSUs at May 31, 2023 | | 1,293 | | | 0.58 | | 0.81 |
| RSUs and PSUs granted | | — | | | | | |
| RSUs and PSUs forfeited | | (1,293) | | | 0.58 | | |
| RSUs and PSUs vested | | — | | | | | |
| Unvested RSUs and PSUs at May 31, 2024 | — | | $— | | — | ||
| (1) | The number of PSUs disclosed in this table are at the target level of 100%. |
Issuance of shares to former and current executives and consultants
During the fiscal year ended May 31, 2022, the employment of our CEO and General Counsel was terminated. Under the terms of their respective employment agreements, the Company was obligated to pay severance equal to 18 months of salary to our former CEO and 12 months of salary to our former General Counsel. As permitted by the employment agreements, in March 2022, the Board authorized the severance payments to our former CEO and the remaining severance payments to our former General Counsel to be made through the issuance of shares of common stock. The shares were issued outside of the 2012 Plan.
During the fiscal year ended May 31, 2023, the Company issued to our former General Counsel a total of 79,391 shares of common stock to satisfy in full its obligation under the terms of the employment agreement. During the same period, consistent with the terms of our former CEO’s employment agreement, the Company also issued 380,704 shares of common stock as severance. The numbers of shares issued were based on the closing price of the common stock on the applicable date. As of December 2022, the Company ceased payment of severance to the Company’s former CEO.
During the fiscal year ended May 31, 2024, the Board approved the issuance under the 2012 Plan of shares of common stock as severance payments to former employees. As a result, a total of 153,027 shares of common stock were issued as severance. The number of shares issued was based on the closing price of the common stock on the payment date.
In order to preserve cash resources, in April 2022, the Board approved the issuance under the 2012 Plan, through November 2022, to then executive officers of shares of common stock with a value equal to 25 percent of salary in lieu of cash, net of payroll deductions and withholding taxes. During the fiscal year ended May 31, 2023, a total of 522,382 shares of common stock were issued pursuant to this cash preservation program. No shares were issued pursuant to this cash preservation program in the fiscal year ended May 31, 2024. The number of shares issued was based on the closing price of the common stock on each payroll date.
In March 2022, the Board approved the issuance under the 2012 Plan of shares of common stock to consultants as payment for services provided. During the fiscal years ended May 31, 2024 and 2023, a total of 2,454,515 and 1,617,760 shares of common stock, respectively, were issued pursuant to the respective award agreements with the consultants.
Note 8. Loss per Common Share
Basic loss per share is computed by dividing the net loss adjusted for preferred stock dividends by the weighted average number of common shares outstanding during the period. Diluted loss per share would include the weighted average common shares outstanding and potentially dilutive common stock equivalents. Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same, since including the additional shares would have an anti-dilutive effect on the loss per share.
The reconciliation of the numerators and denominators of the basic and diluted net loss per share computations are as follows:
| | | | | | |
|---|---|---|---|---|---|
| | Years ended May 31, | ||||
| (in thousands, except per share amounts) · 2024 · · 2023 | |||||
| Net loss | $(49,841) | | $(79,824) | ||
| Less: Deemed dividends | | — | | | (5,417) |
| Less: Accrued preferred stock dividends | | (1,483) | | | (1,495) |
| Net loss applicable to common stockholders | $(51,324) | | $(86,736) | ||
| Basic and diluted: | | | | | |
| Weighted average common shares outstanding | | 969,509 | | | 836,528 |
| Loss per share | $(0.05) | | $(0.10) | ||
Refer to Note 13,* Subsequent Events*for additional information regarding the shares issued subsequent to May 31, 2024.
The table below shows the numbers of shares of common stock issuable upon the exercise, vesting, or conversion of outstanding options, warrants, unvested restricted stock (including those subject to performance conditions), convertible preferred stock (including undeclared dividends), and convertible notes that were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the periods presented:
| | | | | |
|---|---|---|---|---|
| · Year ended May 31, · | ||||
| (in thousands) · 2024 · 2023 · | ||||
| Stock options, warrants, and unvested restricted stock units | 387,294 | | 281,023 | |
| Convertible notes | 12,000 | | 12,000 | |
| Convertible preferred stock | 37,046 | | 34,071 | |
Note 9. Income Taxes
Loss before provision for income taxes was $49.8 million and $79.8 million for the years ended May 31, 2024 and 2023, respectively, all of which was generated in the United States. The Company’s provision for income taxes consists of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| | Years Ended May 31, | |||||
| · · 2024 · · 2023 | ||||||
| Current: | | | | | | |
| Federal | | $— | | $— | ||
| State | | — | | — | ||
| Total Current | | — | | — | ||
| Deferred: | | | | | ||
| Federal | | 57 | | — | ||
| State | | — | | — | ||
| Change in valuation allowance | | | (57) | | | — |
| Total deferred | | | — | | | — |
| Total income tax benefit (expense) | | $— | | $— | ||
The Company’s provision for income tax differs from the amount computed by applying the statutory federal income tax rate to income before taxes as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · Years ended May 31, | |||||
| · 2024 · 2023 | |||||
| Statutory federal income tax rate | 21.0% | 21.0% | |||
| Derivative loss | (0.1) | (2.3) | |||
| Non-deductible debt issuance costs | (7.1) | (2.6) | |||
| Non-deductible interest on convertible notes | (2.0) | (1.2) | |||
| Non-deductible loss on induced conversion | | (2.8) | | (1.4) | |
| Non-deductible debt discount amortization | (0.5) | (0.6) | |||
| Stock Compensation | (7.2) | — | |||
| Other | (1.2) | 0.8 | |||
| Valuation allowance | (0.1) | (13.7) | |||
| Total provision for income taxes | 0.0% | 0.0% | |||
As of May 31, 2024 and 2023, the net deferred tax assets consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| | As of May 31, | |||||
| | 2024 | 2023 | ||||
| Deferred tax assets: | | | | | | |
| Net operating loss | | $100,897 | | $96,338 | ||
| Credits | | 2,063 | | 2,063 | ||
| ASC 718 expense on non-qualified stock options | | 2,665 | | 6,400 | ||
| Accrued expenses | | 411 | | 73 | ||
| Lease liability | | | 59 | | | 89 |
| Inventory charges | | | 6,173 | | | 6,173 |
| Inventory write-off | | | 1,953 | | | 13,739 |
| Contingent liability | | | 9,202 | | | — |
| Issued warrants | | | 3,000 | | | 2,317 |
| Section 174 R&D costs | | | 2,056 | | | 858 |
| Amortization | | 207 | | 609 | ||
| Fixed assets | | 5 | | 4 | ||
| Other | | | — | | | — |
| Total gross deferred tax asset | | | 128,691 | | | 128,663 |
| Less valuation allowance | | | (128,636) | | | (128,579) |
| Total deferred tax assets | | | 55 | | | 84 |
| Deferred tax liabilities: | | | | | | |
| Right-of-use asset | | (55) | | (84) | ||
| Total deferred tax liabilities | | | (55) | | | (84) |
| Net deferred tax asset (liability) | | $— | | $— | ||
Valuation allowances are established when necessary to reduce deferred tax assets, including temporary differences and net operating loss carryforwards, to the amount expected to be realized in the future. FASB guidance indicates that forming a conclusion that a valuation allowance is not needed is difficult when there is negative evidence such as cumulative losses in recent years. The Company had cumulative losses from continuing operations in the United States for the three-year period ended May 31, 2024. The Company considered this negative evidence along with all other available positive and negative evidence and concluded that, at May 31, 2024, it is more likely than not that the Company’s U.S. deferred tax assets will not be realized. As of May 31, 2024, a valuation allowance has been recorded on the Company’s deferred tax assets to recognize only the proportion of the deferred tax asset that is more likely than not to be recognized. The Company’s total valuation allowance was $128.6 million at May 31, 2024 and $128.6 million at May 31, 2023. The Company’s valuation allowance increased $0.1 million and $10.9 million during the fiscal years ended May 31, 2024 and 2023, respectively. A reconciliation of the beginning and ending amount of the valuation allowance is as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| | May 31, | |||
| | | 2024 | | 2023 |
| Valuation allowance at beginning of year | | $128,579 | | $117,638 |
| Change in valuation allowance | | 57 | | 10,941 |
| Valuation allowance at end of year | | $128,636 | | $128,579 |
As of May 31, 2024, the Company had cumulative federal net operating losses of approximately$480.5 million. Of these losses,$47.1 million were generated in 2004 through 2017, prior to the Tax Cuts and Jobs Act enactment, and will expire between 2025 to 2038 if not utilized. The remaining net operating losses have an indefinite carryforward period. As of May 31, 2023, the Company had cumulative federal net operating losses of approximately$458.8 million.
As of May 31, 2024, the Company had a$2.1 million deferred tax asset related to a federal research and development credit carryforward. If not utilized, the credits will expire between 2035 through 2038. As of May 31, 2023, the Company had a$2.1 million deferred tax asset related to a federal research and development credit carryforward.
As of May 31, 2024, the U.S. tax returns for fiscal year 2004 through fiscal year 2023 remain subject to examination. Annual tax provisions include amounts considered necessary to pay assessments that may result from examination of prior year tax returns; however, the amount ultimately paid upon resolution of issues may differ materially from the amount accrued. As of May 31, 2024, there are no income tax returns currently under audit.
On August 16, 2022, the Inflation Reduction Act (“IRA”) was signed into law by President Biden. The IRA includes a corporate minimum tax of 15% on certain large corporations with greater than$1 B in average adjusted financial statement income and an excise tax on certain stock repurchases executed after December 31, 2022. There are no impacts to the Company in 2024, and the Company does not expect a material impact on its consolidated financial statements in the future for the IRA.
On December 14, 2023, the FASB issued ASU 2023-09 (Improvements to Income Tax Disclosures). The object of the project is to improve the transparency and usefulness of income tax disclosures. For public business entities, the effective date is for fiscal years beginning after December 15, 2024. The Company does not expect a material impact on its consolidated financial statements related to ASU 2023-09.
Note 10. Commitments and Contingencies
Commitments with Samsung BioLogics Co., Ltd. (“Samsung”)
In April 2019, the Company entered into several agreements with Samsung, pursuant to which Samsung agreed to perform technology transfer, process validation, manufacturing, pre-approval inspection, and supply services for the commercial supply of leronlimab bulk drug substance. In 2020, the Company entered into an additional agreement, pursuant to which Samsung agreed to perform technology transfer, process validation, vial filling, and storage services for clinical, pre-approval inspection, and commercial supply of leronlimab drug product.
On January 6, 2022, Samsung provided written notice to the Company alleging that the Company had materially breached the parties’ Master Services and Project Specific Agreements (the “Samsung Agreements”) for failure to pay an outstanding balance due on December 31, 2021.
On November 21, 2023, Samsung informed the Company of Samsung’s intent to terminate the Samsung Agreements, effective January 5, 2024. Thereafter, the parties continued the negotiations that were already in progress in relation to the outstanding issues under the agreements and potential options moving forward.
On April 3, 2024, the Company and Samsung executed a side letter agreement (the “Letter Agreement”), 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 Letter Agreement, is now 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 Letter Agreement. Under the Letter Agreement, 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 Letter Agreement 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).”
Since the carrying amount of the payable is equal to potential future cash flows, no gain was recognized. The $250,000 payment due on or before December 31, 2024, is included in accounts payable on the balance sheet, and the remaining balance of approximately $43.5 million is included in other liabilities.
PRO 140 Acquisition and Licensing Arrangements
We originally acquired leronlimab, as well as certain other related assets, including the existing inventory of PRO 140 bulk drug substance, intellectual property, and FDA regulatory filings, pursuant to an Asset Purchase Agreement, dated as of July 25, 2012, and effective October 16, 2012 (the “Progenics Purchase Agreement”), between CytoDyn and Progenics. Pursuant to the Progenics Purchase Agreement, we are required to pay Progenics a milestone payment and royalties as follows: (i) $5,000,000 at the time of the first U.S. new drug application approval by the FDA or other non-U.S. approval for the sale of leronlimab; and (ii) royalty payments of up to 5% on net sales during the period beginning on the date of the first commercial sale of leronlimab until the later of (a) the expiration of the last to expire patent included in the acquired assets, and (b) 10 years, in each case determined on a country-by-country basis. To the extent that such remaining milestone payment and royalties are not timely made, under the terms of the Progenics Purchase Agreement, Progenics has certain repurchase rights relating to the assets sold to us thereunder.
Payments to Progenics are in addition to payments due under a Development and License Agreement, dated April 30, 1999 (the “PDL License”), between Protein Design Labs (now AbbVie Inc.) and Progenics, which was assigned to us in the Progenics Purchase Agreement, pursuant to which we have an exclusive worldwide license to develop, make, have made, import, use, sell, offer to sell, or have sold products that incorporate the humanized form of the leronlimab antibody developed under the agreement. Pursuant to the PDL License, we are required to pay AbbVie Inc. milestone payments and royalties as follows: (i) $500,000 upon filing a Biologic License Application with the FDA or non-U.S. equivalent regulatory body; (ii) $500,000 upon FDA approval or approval by another non-U.S. equivalent regulatory body; and (iii) royalties of up to 3.5% of net sales for the longer of 10 years and the date of expiration of the last to expire licensed patent. Additionally, the PDL License provides for an annual maintenance fee of $150,000 until royalties paid exceed that amount. To the extent that such remaining milestone payments and royalties are not timely made, under the terms of the PDL License, AbbVie Inc. has certain termination rights relating to our license of leronlimab thereunder.
Effective July 29, 2015, we entered into a License Agreement (the “Lonza Agreement”) with Lonza Sales AG (“Lonza”) covering Lonza’s “system know-how” technology with respect to our use of proprietary cell lines to manufacture new leronlimab material. The Lonza Agreement provides for an annual license fee and future royalty payments, both of which vary based on whether Lonza, or we or our strategic partner manufactures leronlimab. We currently usetwo independent parties as contract manufacturers for leronlimab, and continually review this arrangement. Should the arrangement continue as-is, an annual license fee of £0.3 million (approximately $0.35 million given current exchange rate) would continue to apply, as well as a royalty, up to 2% of the net selling price upon commercialization of leronlimab, excluding value added taxes and similar amounts.
Operating Leases
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
fiscal years ended May 31, 2024 and 2023 were approximately $0.1 million and $0.2 million, respectively. Operating lease right-of-use assets are included in other non-current assets and the current portion of operating lease liabilities are included in accrued liabilities and compensation on the consolidated balance sheets. The long-term operating lease liabilities are presented separately as operating leases on the consolidated balance sheets. The following table summarizes the operating lease balances.
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · · | |||||||
| (in thousands) | | | May 31, 2024 | | | May 31, 2023 | |
| Assets | | | | | | | |
| Right-of-use asset | | $264 | | $400 | | ||
| Liabilities | | | | | | | |
| Current operating lease liability | | $142 | | $139 | | ||
| Non-current operating lease liability | | 141 | | 283 | | ||
| Total operating lease liability | | $283 | | $422 | | ||
The minimum (base rental) lease payments reconciled to the carrying value of the operating lease liabilities as of May 31, 2024, are expected to be as follows (in thousands):
| | | | |
|---|---|---|---|
| Fiscal Year · · Amount | |||
| 2025 | | $185 | |
| 2026 | | | 169 |
| Thereafter | | | — |
| Total operating lease payments | | | 354 |
| Less: imputed interest | | | (71) |
| Present value of operating lease liabilities | | $283 | |
Supplemental information related to the operating leases was as follows:
| | | | |
|---|---|---|---|
| · · May 31, 2024 | |||
| Weighted average remaining lease term | | 1.9 | years |
| Weighted average discount rate | | 10.0% | |
Legal Proceedings
The Company is a party to various legal proceedings. The Company recognizes accruals for such proceedings to the extent a loss is determined to be both probable and reasonably estimable. The best estimate of a loss within a possible range is accrued; however, if no estimate in the range is more probable than another, then the minimum amount in the range is accrued. If it is determined that a material loss is not probable but reasonably possible and the loss or range of loss can be estimated, the possible loss is disclosed. It is not possible to determine the outcome of proceedings that have not been concluded, including the defense and other litigation-related costs and expenses that may be incurred by the Company, as the outcomes of legal proceedings are inherently uncertain, and the outcomes could differ significantly from recognized accruals. Therefore, it is possible that the ultimate outcome of any proceeding, if in excess of a recognized accrual, or if an accrual had not been made, could be material to the Company’s consolidated financial statements.
Securities Class Action Lawsuit**s
On March 17, 2021, a stockholder filed a putative class-action lawsuit (the “March 17, 2021 lawsuit”) in the U.S. District Court for the Western District of Washington against the Company and certain former officers. The complaint generally alleges the defendants made false and misleading statements regarding the viability of leronlimab as a potential treatment for COVID-19. On April 9, 2021, a second stockholder filed a similar putative class action lawsuit in the same court, which the plaintiff voluntarily dismissed without prejudice on July 23, 2021. On August 9, 2021, the court appointed lead plaintiffs for the March 17, 2021 lawsuit. On December 21, 2021, lead plaintiffs filed an amended complaint, which is brought on behalf of an alleged class of those who purchased the Company’s common stock between March 27, 2020 and May 17, 2021. The amended complaint generally alleges that the defendants violated Sections 10(b) and/or 20(a) of the 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, and asserts the same claims as the prior complaint, adds a claim for alleged violation of Section 10(b) of the Exchange Act and Rule 10b-5(a) and (c) promulgated thereunder, and seeks the same relief as the prior complaint. All defendants have filed motions to dismiss the second amended complaint in whole or in part. The Company and the individual defendants deny all allegations of wrongdoing in the complaint and intend to vigorously defend the matter. Since this case is in an early stage where the number of plaintiffs is not known, and the claims do not specify an amount of damages, the Company is unable to predict the ultimate outcome of the lawsuit and cannot reasonably estimate the potential loss or range of loss the Company may incur.
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 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 Clinical Research, LLC (“Amarex”), the Company’s former clinical research organization (“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.
Note 11. Related Party Transactions
The Board’s Audit Committee and the Board of Directors review and approve all related party transactions. The terms and amounts described below are not necessarily indicative of the terms and amounts that could have been incurred had comparable transactions been entered into with independent parties.
On February 13, 2023, Cyrus Arman, then the Company’s President, entered into a private placement with the Company in which he purchased approximately 0.4 million units consisting ofone share of common stock andone warrant to purchaseone share of common stock at an exercise price of $0.50. The terms and conditions of the investment totaling $0.1 million made by Mr. Arman were identical to those offered to other investors in a concurrent offering being conducted through a placement agent.
Note 12. Employee Benefit Plan
The Company has an employee savings plan (the “401(k) Plan”), organized under Section 401(k) of the Internal Revenue Code (the “Code”), covering all employees. The Company makes a qualified non-elective contribution of 3%, which vests immediately. In addition, participants in the 401(k) Plan may contribute a percentage of their compensation, but not greater than the maximum allowed under the Code. During the fiscal years ended May 31, 2024 and 2023, the Company incurred an expense of approximately $0.1 million for qualified non-elective contributions.
Note 13. Subsequent Events
Tender offer
On July 19, 2024, the Company closed a tender offer where 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 $10.5 million. The Company also issued approximately 25.4 million shares of common stock as bonus shares in the tender offer.
Induced note conversions
On July 8, 2024, in satisfaction of a redemption, the Company and the April 23, 2021 Noteholder entered into an exchange agreement, pursuant to which a portion of the April 23, 2021 Note was partitioned into a new note with an aggregate principal amount of $0.5 million, which was exchanged concurrently for approximately 3.9 million shares.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.